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EUDAMED Device Search

A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.

Last updated

21.09.2026 21:15

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187 device results listed.

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Phosphorylated Tau-181 Protein Rapid Test(Whole blood/Serum/Plasma)

Phosphorylated Tau-181 Protein Rapid Test(Whole blood/Serum/Plasma)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646TAU181-001RMX4
Basic UDI-DI: B-697424646TAU181-001RMX4
Reference: Tau181-4011/Tau181-4012
EMDN: W0102160199
EMDN description: SPECIFIC PROTEINS RT & POC - OTHER
First on market country: Germany
Authorised representative: UnicareQ GmbH
Last updated: 17.07.2026 04:15

Manufacturer products Authorised representative products Authorised representative actors View details

Syphilis Rapid Test (Serum/Plasma)

Syphilis Rapid Test (Serum/Plasma)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646SYP002U9EG
Basic UDI-DI: B-697424646SYP002U9EG
Reference: SYP-3011/SYP-4011
EMDN: W0105090105
EMDN description: SYPHILIS - RT & POC
First on market country: Germany
Authorised representative: UnicareQ GmbH
Last updated: 17.07.2026 04:15

Manufacturer products Authorised representative products Authorised representative actors View details

Syphilis Rapid Test (Whole Blood/Serum/Plasma)

Syphilis Rapid Test (Whole Blood/Serum/Plasma)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646SYP001U7E7
Basic UDI-DI: B-697424646SYP001U7E7
Reference: SYP-4011/SYP-4012
EMDN: W0105090105
EMDN description: SYPHILIS - RT & POC
First on market country: Germany
Authorised representative: UnicareQ GmbH
Last updated: 17.07.2026 04:15

Manufacturer products Authorised representative products Authorised representative actors View details

Strep B Rapid Test (Swab)

Strep B Rapid Test (Swab)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646STB001PE67
Basic UDI-DI: B-697424646STB001PE67
Reference: STB-6011/STB-6012
EMDN: W0105090104
EMDN description: STREP. B - RT & POC
First on market country: Germany
Authorised representative: UnicareQ GmbH
Last updated: 17.07.2026 04:15

Manufacturer products Authorised representative products Authorised representative actors View details

Strep A Rapid Test (Swab)

Strep A Rapid Test (Swab)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646STA001P74Y
Basic UDI-DI: B-697424646STA001P74Y
Reference: STA-6011/STA-6012
EMDN: W0105090103
EMDN description: STREP. A - RT & POC
First on market country: Germany
Authorised representative: UnicareQ GmbH
Last updated: 17.07.2026 04:15

Manufacturer products Authorised representative products Authorised representative actors View details

SP10 Protein Rapid Test(Semen)

SP10 Protein Rapid Test(Semen)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646SP10001LA35
Basic UDI-DI: B-697424646SP10001LA35
Reference: SP10-6012
EMDN: W0102160199
EMDN description: SPECIFIC PROTEINS RT & POC - OTHER
First on market country: Germany
Authorised representative: UnicareQ GmbH
Last updated: 17.07.2026 04:14

Manufacturer products Authorised representative products Authorised representative actors View details

Carisoprodol(SOMA) Rapid Test(Saliva)

Carisoprodol(SOMA) Rapid Test(Saliva)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646SOMA002YQRR
Basic UDI-DI: B-697424646SOMA002YQRR
Reference: SOMA-7011/SOMA-7012/SOMA-7014/SOMA-7015
EMDN: W0102160599
EMDN description: DRUGS OF ABUSE/TOXICOLOGY RT & POC - OTHER
First on market country: Germany
Authorised representative: UnicareQ GmbH
Last updated: 17.07.2026 04:14

Manufacturer products Authorised representative products Authorised representative actors View details

Carisoprodol(SOMA) Rapid Test(Urine)

Carisoprodol(SOMA) Rapid Test(Urine)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646SOMA001YNRE
Basic UDI-DI: B-697424646SOMA001YNRE
Reference: SOMA-1011/SOMA-1012/SOMA-1014
EMDN: W0102160599
EMDN description: DRUGS OF ABUSE/TOXICOLOGY RT & POC - OTHER
First on market country: Germany
Authorised representative: UnicareQ GmbH
Last updated: 17.07.2026 04:14

Manufacturer products Authorised representative products Authorised representative actors View details

Rubella.Virus(RV) IgM/IgG Test(Serum/Plasma)

Rubella.Virus(RV) IgM/IgG Test(Serum/Plasma)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646RV001LJS2
Basic UDI-DI: B-697424646RV001LJS2
Reference: RV-3022
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: UnicareQ GmbH
Last updated: 17.07.2026 04:14

Manufacturer products Authorised representative products Authorised representative actors View details

Rubella.Virus(RV) IgM/IgG Test(Whole Blood/Serum/Plasma)

Rubella.Virus(RV) IgM/IgG Test(Whole Blood/Serum/Plasma)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646RV000LGRP
Basic UDI-DI: B-697424646RV000LGRP
Reference: RV-4022
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: UnicareQ GmbH
Last updated: 17.07.2026 04:14

Manufacturer products Authorised representative products Authorised representative actors View details

RSV Antigen Rapid Test(Swab)

RSV Antigen Rapid Test(Swab)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646RSV001T2CF
Basic UDI-DI: B-697424646RSV001T2CF
Reference: RSV-6011/RSV-6012
EMDN: W0105099002
EMDN description: RSV - RT & POC
First on market country: Germany
Authorised representative: UnicareQ GmbH
Last updated: 17.07.2026 04:14

Manufacturer products Authorised representative products Authorised representative actors View details

RSV Antigen FIA Test (Swab)

RSV Antigen FIA Test (Swab)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646RSV000F2PR2
Basic UDI-DI: B-697424646RSV000F2PR2
Reference: RSV-6012F
EMDN: W0105099002
EMDN description: RSV - RT & POC
First on market country: Germany
Authorised representative: UnicareQ GmbH
Last updated: 17.07.2026 04:14

Manufacturer products Authorised representative products Authorised representative actors View details

Rotavirus-Adenovirus Combo Rapid Test (Feces)

Rotavirus-Adenovirus Combo Rapid Test (Feces)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646ROT003RCAM
Basic UDI-DI: B-697424646ROT003RCAM
Reference: ROT-5022
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: UnicareQ GmbH
Last updated: 17.07.2026 04:14

Manufacturer products Authorised representative products Authorised representative actors View details

Rotavirus Antigen Rapid Test(Feces)

Rotavirus Antigen Rapid Test(Feces)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646ROT002RAAC
Basic UDI-DI: B-697424646ROT002RAAC
Reference: ROT-5011/ROT-5012
EMDN: W0105090104
EMDN description: STREP. B - RT & POC
First on market country: Germany
Authorised representative: UnicareQ GmbH
Last updated: 17.07.2026 04:14

Manufacturer products Authorised representative products Authorised representative actors View details

Psilocybin(PSI) Rapid Test (Urine)

Strip: PSI-1011；Cassette: PSI-1012；Dip Card: PSI-1014；Cup:PSI-1015

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646PSI000PB6D
Basic UDI-DI: B-697424646PSI000PB6D
Reference: PSI-1011/PSI-1012/PSI-1014/PSI-1015
EMDN: W0102160599
EMDN description: DRUGS OF ABUSE/TOXICOLOGY RT & POC - OTHER
First on market country: Germany
Authorised representative: UnicareQ GmbH
Last updated: 17.07.2026 04:14

Manufacturer products Authorised representative products Authorised representative actors View details

Propoxyphene(PPX) Rapid Test (Urine)

Propoxyphene(PPX) Rapid Test (Urine)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646PPX001RMBW
Basic UDI-DI: B-697424646PPX001RMBW
Reference: PPX-1011/PPX-1012/PPX-1014
EMDN: W0102160599
EMDN description: DRUGS OF ABUSE/TOXICOLOGY RT & POC - OTHER
First on market country: Germany
Authorised representative: UnicareQ GmbH
Last updated: 17.07.2026 04:14

Manufacturer products Authorised representative products Authorised representative actors View details

BV pH Rapid Test

BV pH Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646PH001GSKD
Basic UDI-DI: B-697424646PH001GSKD
Reference: PH-6011/PH-6012
EMDN: W01010699
EMDN description: CLIN. CHEM. RT & POC - OTHER
First on market country: Germany
Authorised representative: UnicareQ GmbH
Last updated: 17.07.2026 04:14

Manufacturer products Authorised representative products Authorised representative actors View details

Pregabalin Rapid Test(Urine)

Pregabalin Rapid Test(Urine)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646PGB001HQVE
Basic UDI-DI: B-697424646PGB001HQVE
Reference: PGB-1011/PGB-1012/PGB-1014
EMDN: W0102160599
EMDN description: DRUGS OF ABUSE/TOXICOLOGY RT & POC - OTHER
First on market country: Germany
Authorised representative: UnicareQ GmbH
Last updated: 17.07.2026 04:14

Manufacturer products Authorised representative products Authorised representative actors View details

Procalcitonin FIA Test (Whole blood/Serum/Plasma)

Procalcitonin FIA Test (Whole blood/Serum/Plasma)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646PCT000FSCF8
Basic UDI-DI: B-697424646PCT000FSCF8
Reference: PCT-4012F
EMDN: W01021699
EMDN description: RAPID TESTS & POINT OF CARE - IMMUNOCHEMISTRY - OTHER
First on market country: Germany
Authorised representative: UnicareQ GmbH
Last updated: 17.07.2026 04:14

Manufacturer products Authorised representative products Authorised representative actors View details

Procalcitonin FIA Test (Serum/Plasma)

Procalcitonin FIA Test (Serum/Plasma)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646PCT001FSFFM
Basic UDI-DI: B-697424646PCT001FSFFM
Reference: PCT-3012F
EMDN: W01021699
EMDN description: RAPID TESTS & POINT OF CARE - IMMUNOCHEMISTRY - OTHER
First on market country: Germany
Authorised representative: UnicareQ GmbH
Last updated: 17.07.2026 04:14

Manufacturer products Authorised representative products Authorised representative actors View details