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01.08.2026 18:27

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Insulin CLIA Microparticles

AutoLumo Analyzer

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359543361
Basic UDI-DI: 697015090000072H9
Reference: CMG0103
EMDN: W0102060103
EMDN description: INSULIN
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 20:49

Manufacturer products Authorised representative products Authorised representative actors View details

25-OH Vitamin D CLIA Microparticles

AutoLumo analyzer

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359542364
Basic UDI-DI: 697015090000075HF
Reference: CMS0403
EMDN: W0102060309
EMDN description: 25-HYDROXYVITAMIN D
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 20:49

Manufacturer products Authorised representative products Authorised representative actors View details

Calcitonin CLIA Microparticles

AutoLumo analyzer

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359542463
Basic UDI-DI: 697015090000048HC
Reference: CMS0603
EMDN: W0102060301
EMDN description: CALCITONIN
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 20:49

Manufacturer products Authorised representative products Authorised representative actors View details

Osteocalcin CLIA Microparticles

AutoLumo analyzer

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359542265
Basic UDI-DI: 697015090000045H6
Reference: CMS0103
EMDN: W0102060311
EMDN description: OSTEOCALCINE
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 20:49

Manufacturer products Authorised representative products Authorised representative actors View details

Cortisol (CLIA)

105-005673-00、105-005690-00、105-005924-00

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053158107
Basic UDI-DI: 69449040004L-Cortisol**MW
Reference: 105-064665-00
EMDN: W0102060203
EMDN description: CORTISOL
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:53

Manufacturer products Authorised representative products Authorised representative actors View details

C-Peptide(CLIA)

105-005667-00、105-005684-00、105-005918-00

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

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053157612
Basic UDI-DI: 69449040004L-C-Peptide*NZ
Reference: 105-064663-00
EMDN: W0102060101
EMDN description: C-PEPTIDE
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:53

Manufacturer products Authorised representative products Authorised representative actors View details

Adrenocorticotropic hormone(CLIA)

105-005675-00、105-005692-00、105-005926-00、105-005939-00、105-005953-00、105-005940-00、105-005954-00

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

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053156578
Basic UDI-DI: 69449040004L-ACTH******ES
Reference: 105-064669-00
EMDN: W0102060401
EMDN description: ADRENOCORTIOTROPIC HORMONE
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:53

Manufacturer products Authorised representative products Authorised representative actors View details

Insulin (CLIA)

105-005666-00、105-005683-00、105-005917-00

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053156516
Basic UDI-DI: 69449040004L-Insulin***FX
Reference: 105-064662-00
EMDN: W0102060103
EMDN description: INSULIN
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:53

Manufacturer products Authorised representative products Authorised representative actors View details

AngiotensinⅠ(CLIA)

105-049534-00/105-049536-00

IVD Class BIVDR 2017/746On the marketHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053093828
Basic UDI-DI: 69449040AB740006968
Reference: 105-049536-00
EMDN: W0102060202
EMDN description: ANGIOTENSIN I / II
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:52

Manufacturer products Authorised representative products Authorised representative actors View details

Angiotensin Ⅱ(CLIA)

105-049533-00、105-049532-00、105-051448-00、

IVD Class BIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053093750
Basic UDI-DI: 69449040AB74000715T
Reference: 105-049533-00
EMDN: W0102060202
EMDN description: ANGIOTENSIN I / II
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:52

Manufacturer products Authorised representative products Authorised representative actors View details

25-OH-Vitamin D Total (CLIA)

105-045515-00、105-045516-00

IVD Class BIVDR 2017/746On the marketDirect markingProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053074063
Basic UDI-DI: 69449040AB74000485Y
Reference: 105-045516-00
EMDN: W0102060309
EMDN description: 25-HYDROXYVITAMIN D
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:51

Manufacturer products Authorised representative products Authorised representative actors View details

Total-P1NP (CLIA)

105-043537-00、105-043538-00、105-045132-00

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053069908
Basic UDI-DI: 69449040AB74000615Q
Reference: 105-043537-00
EMDN: W0102060317
EMDN description: PROCOLLAGEN TYPE I N TERMINAL PROPEPTIDE
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:51

Manufacturer products Authorised representative products Authorised representative actors View details

Renin (CLIA)

105-031482-00、105-031483-00

IVD Class BIVDR 2017/746On the marketHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053062008
Basic UDI-DI: 69449040AB74000095N
Reference: 105-031482-00
EMDN: W0102060204
EMDN description: RENINE (PLASMA RENINE ACTIVITY)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:50

Manufacturer products Authorised representative products Authorised representative actors View details

Aldosterone (CLIA)

105-029848-00/105-031481-00

IVD Class BIVDR 2017/746On the marketHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053061988
Basic UDI-DI: 69449040AB74000085L
Reference: 105-029848-00
EMDN: W0102060201
EMDN description: ALDOSTERONE
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:50

Manufacturer products Authorised representative products Authorised representative actors View details

Gastrin-17 (CLIA)

105-029891-00、105-029892-00

IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053060950
Basic UDI-DI: 69449040AB74000375T
Reference: 105-029892-00
EMDN: W0102069001
EMDN description: GASTRIN
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:50

Manufacturer products Authorised representative products Authorised representative actors View details

Insulin-like Growth Factor-1 (CLIA)

Please see UDI-DI for details

IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053045100
Basic UDI-DI: 69449040AB74000475W
Reference: 105-037748-00
EMDN: W0102060403
EMDN description: INSULIN-LIKE GROWTH FACTOR I (SOMATOMEDIN C)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:49

Manufacturer products Authorised representative products Authorised representative actors View details

Human Growth Hormone (CLIA)

105-037749-00、105-037750-00、105-037732-00、105-037733-00

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053045094
Basic UDI-DI: 69449040AB74000265N
Reference: 105-037732-00
EMDN: W0102060402
EMDN description: HUMAN GROWTH HORMONE
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:49

Manufacturer products Authorised representative products Authorised representative actors View details

06926802603581

PCT（CLIA）

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.
Manufacturer SRN: CN-MF-000005925
UDI-DI: 06926802603581
Basic UDI-DI: 69268026MD71F00001VR
Reference: MCL02101E
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Netherlands
Authorised representative: R Sight B.V.
Last updated: 31.07.2026 18:41

Manufacturer products Authorised representative products Authorised representative actors View details

iFlash-GADA Ⅲ

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912737964
Basic UDI-DI: 692591270327HL
Reference: C86368
EMDN: W0102060105
EMDN description: GAD II ANTIBODIES AND OTHER ICA
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

iFlash-25-OH Vitamin D Ⅱ

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912724285
Basic UDI-DI: 692591270278HY
Reference: C86326
EMDN: W0102060309
EMDN description: 25-HYDROXYVITAMIN D
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 18:36

Manufacturer products Authorised representative products Authorised representative actors View details