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319 device results listed.

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IDS ANCA/GBM Control Set

IVD generalIVDDOn the marketHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Immunodiagnostic Systems Limited
Manufacturer SRN: GB-MF-000015851
UDI-DI: 05060169694064
Basic UDI-DI: B-05060169694064
Reference: IS-AI1730
EMDN: W0102152011
EMDN description: CONTROLS FOR AUTOIMMUNITY
First on market country: Belgium
Authorised representative: Immunodiagnostic Systems SA
Last updated: 02.08.2026 18:00

Manufacturer products Authorised representative products Authorised representative actors View details

Autoimmune Maker Control I

AutoLumo analyzer

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359520560
Basic UDI-DI: 697015090000127H9
Reference: ZKE010101
EMDN: W0102152011
EMDN description: CONTROLS FOR AUTOIMMUNITY
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 20:48

Manufacturer products Authorised representative products Authorised representative actors View details

Histones IgG Control

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912738909
Basic UDI-DI: 692591270353HM
Reference: CC359
EMDN: W0102152011
EMDN description: CONTROLS FOR AUTOIMMUNITY
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 18:38

Manufacturer products Authorised representative products Authorised representative actors View details

ANA Control

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912738831
Basic UDI-DI: 692591270132H3
Reference: CC830
EMDN: W0102152011
EMDN description: CONTROLS FOR AUTOIMMUNITY
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 18:38

Manufacturer products Authorised representative products Authorised representative actors View details

dsDNA IgG Control

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912738824
Basic UDI-DI: 692591270122GY
Reference: CC831
EMDN: W0102152011
EMDN description: CONTROLS FOR AUTOIMMUNITY
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 18:38

Manufacturer products Authorised representative products Authorised representative actors View details

SMA IgG Control

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912738688
Basic UDI-DI: 692591270331HB
Reference: CC367
EMDN: W0102152011
EMDN description: CONTROLS FOR AUTOIMMUNITY
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 18:38

Manufacturer products Authorised representative products Authorised representative actors View details

Autoimmune Diabetes Multi Control

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912738626
Basic UDI-DI: 692591270126H8
Reference: CC829
EMDN: W0102152011
EMDN description: CONTROLS FOR AUTOIMMUNITY
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 18:38

Manufacturer products Authorised representative products Authorised representative actors View details

DGP IgA Control

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912738336
Basic UDI-DI: 692591270324HE
Reference: CC405
EMDN: W0102152011
EMDN description: CONTROLS FOR AUTOIMMUNITY
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 18:38

Manufacturer products Authorised representative products Authorised representative actors View details

DGP IgG Control

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912738329
Basic UDI-DI: 692591270323HC
Reference: CC404
EMDN: W0102152011
EMDN description: CONTROLS FOR AUTOIMMUNITY
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 18:38

Manufacturer products Authorised representative products Authorised representative actors View details

tTG IgG Control

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912738305
Basic UDI-DI: 692591270321H8
Reference: CC402
EMDN: W0102152011
EMDN description: CONTROLS FOR AUTOIMMUNITY
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 18:38

Manufacturer products Authorised representative products Authorised representative actors View details

tTG IgA Control

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912738312
Basic UDI-DI: 692591270322HA
Reference: CC403
EMDN: W0102152011
EMDN description: CONTROLS FOR AUTOIMMUNITY
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 18:38

Manufacturer products Authorised representative products Authorised representative actors View details

AMA-M2 Control

IVD Class BIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagent

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912738299
Basic UDI-DI: 692591270245HH
Reference: CC366
EMDN: W0102152011
EMDN description: CONTROLS FOR AUTOIMMUNITY
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 18:37

Manufacturer products Authorised representative products Authorised representative actors View details

CenpB IgG Control

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912738183
Basic UDI-DI: 692591270352HK
Reference: CC1025
EMDN: W0102152011
EMDN description: CONTROLS FOR AUTOIMMUNITY
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 18:37

Manufacturer products Authorised representative products Authorised representative actors View details

SpermMar Test IgG Positive Control

SPMG_P

IVD Class BIVDR 2017/746On the marketDirect markingHuman tissuesProfessional testingReagent

Manufacturer: FertiPro
Manufacturer SRN: BE-MF-000000313
UDI-DI: 05411967001378
Basic UDI-DI: 5411967SPMGP12U
Reference: SPMG_P
EMDN: W0102152011
EMDN description: CONTROLS FOR AUTOIMMUNITY
First on market country: Belgium
Authorised representative: -
Last updated: 31.07.2026 10:52

Manufacturer products View details

SpermMar Test IgG Negative Control

SPMG_N

IVD Class BIVDR 2017/746On the marketDirect markingHuman tissuesProfessional testingReagent

Manufacturer: FertiPro
Manufacturer SRN: BE-MF-000000313
UDI-DI: 05411967001361
Basic UDI-DI: 5411967SPMGN12N
Reference: SPMG_N
EMDN: W0102152011
EMDN description: CONTROLS FOR AUTOIMMUNITY
First on market country: Belgium
Authorised representative: -
Last updated: 31.07.2026 10:52

Manufacturer products View details

IMMULITE Thyroid Autoantibody Control Module

IVDR_67_LLB_DUB-C_B_REAG_Thyroid Autoantibody Con Mod

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesProfessional testingReagentSingle use

Manufacturer: Siemens Healthcare Diagnostics Products Ltd.
Manufacturer SRN: GB-MF-000016339
UDI-DI: 00630414953335
Basic UDI-DI: 0405686900671VQ
Reference: 10385381
EMDN: W0102152011
EMDN description: CONTROLS FOR AUTOIMMUNITY
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 22.07.2026 09:09

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA Centaur NfL Quality Control (NfL QC)

IVDR_67_TTN_DUB-C_C_REAG_sNfL Control

IVD Class CIVDR 2017/746On the marketHuman tissuesMicrobial substancesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414635453
Basic UDI-DI: 0405686902257VQ
Reference: 11553994
EMDN: W0102152011
EMDN description: CONTROLS FOR AUTOIMMUNITY
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:37

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica IM aTgII Master Curve Material (aTgII MCM)

IVDR_67_LLB_DUB-C_B_REAG_aTgII MCM

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Products Ltd.
Manufacturer SRN: GB-MF-000016339
UDI-DI: 00630414245348
Basic UDI-DI: 0405686901418VH
Reference: 11201751
EMDN: W0102152011
EMDN description: CONTROLS FOR AUTOIMMUNITY
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:23

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica IM aTgII Quality Control (aTgII QC)

IVDR_67_LLB_DUB-C_B_REAG_aTgII QC Material

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Products Ltd.
Manufacturer SRN: GB-MF-000016339
UDI-DI: 00630414245331
Basic UDI-DI: 0405686901419VK
Reference: 11201752
EMDN: W0102152011
EMDN description: CONTROLS FOR AUTOIMMUNITY
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:23

Manufacturer products Authorised representative products Authorised representative actors View details

Autoimmune Control Solution (FIA)

VIC151-10-011

IVD generalIVDDOn the marketAnimal tissuesProfessional testing

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: D-VIC151EP
Basic UDI-DI: B-VIC151EP
Reference: VIC151-10-011
EMDN: W0102152011
EMDN description: CONTROLS FOR AUTOIMMUNITY
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 15.07.2026 13:18

Manufacturer products Authorised representative products Authorised representative actors View details