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EUDAMED Device Search

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

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03.08.2026 06:01

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583 device results listed.

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FUN Control

105-002195-00、105-002196-00、105-002197-00、105-020477-00

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

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06936415986476
Basic UDI-DI: 69449040004EFUN********G8
Reference: 105-020477-00
EMDN: W0101050299
EMDN description: SPECIFIC CONTROLS (CC) - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:42

Manufacturer products Authorised representative products Authorised representative actors View details

AFU Control

please see UDI-DI for details

IVD Class CIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06936415986421
Basic UDI-DI: 694490400043AFU********F3
Reference: 105-020474-00
EMDN: W0101050201
EMDN description: ENZYME CONTROLS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:41

Manufacturer products Authorised representative products Authorised representative actors View details

06935740739597

ISE Quality Control Material

IVD Class BIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: URIT Medical Electronic Co.,Ltd.
Manufacturer SRN: CN-MF-000011840
UDI-DI: 06935740739597
Basic UDI-DI: 69357407ICAS000040AS
Reference: /
EMDN: W0101050204
EMDN description: ELECTROLYTE CONTROLS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:04

Manufacturer products Authorised representative products Authorised representative actors View details

Lipotrol HDL/LDL Abnormal

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

Manufacturer: Thermo Fisher Scientific Oy
Manufacturer SRN: FI-MF-000001479
UDI-DI: 16438153819070
Basic UDI-DI: 6438153BU00142BN
Reference: 981907
EMDN: W0101050202
EMDN description: LIPID CONTROLS
First on market country: Finland
Authorised representative: -
Last updated: 02.07.2026 09:07

Manufacturer products View details

05902643962279

BioPath R

IVD Class CIVDR 2017/746On the marketProfessional testing

Manufacturer: BioMaxima Spółka Akcyjna
Manufacturer SRN: PL-MF-000039473
UDI-DI: 05902643962279
Basic UDI-DI: 59026439CBCH814BT
Reference: 1-814-0001
EMDN: W0101050299
EMDN description: SPECIFIC CONTROLS (CC) - OTHER
First on market country: Poland
Authorised representative: -
Last updated: 02.07.2026 05:28

Manufacturer products View details

05902643962262

BioNorm R

IVD Class CIVDR 2017/746On the marketProfessional testing

Manufacturer: BioMaxima Spółka Akcyjna
Manufacturer SRN: PL-MF-000039473
UDI-DI: 05902643962262
Basic UDI-DI: 59026439CBCH813BR
Reference: 1-813-0001
EMDN: W0101050299
EMDN description: SPECIFIC CONTROLS (CC) - OTHER
First on market country: Poland
Authorised representative: -
Last updated: 02.07.2026 05:28

Manufacturer products View details

05902643962255

KONTROLA CRP - Poziom 2 (1 ml)

IVD Class CIVDR 2017/746On the marketProfessional testing

Manufacturer: BioMaxima Spółka Akcyjna
Manufacturer SRN: PL-MF-000039473
UDI-DI: 05902643962255
Basic UDI-DI: 59026439CBCH812BP
Reference: 1-812-0001
EMDN: W0101050299
EMDN description: SPECIFIC CONTROLS (CC) - OTHER
First on market country: Poland
Authorised representative: -
Last updated: 02.07.2026 05:28

Manufacturer products View details

05902643962248

KONTROLA CRP - Poziom 1 (1 ml)

IVD Class CIVDR 2017/746On the marketProfessional testing

Manufacturer: BioMaxima Spółka Akcyjna
Manufacturer SRN: PL-MF-000039473
UDI-DI: 05902643962248
Basic UDI-DI: 59026439CBCH811BM
Reference: 1-811-0001
EMDN: W0101050299
EMDN description: SPECIFIC CONTROLS (CC) - OTHER
First on market country: Poland
Authorised representative: -
Last updated: 02.07.2026 05:28

Manufacturer products View details

MULTI-SYSTEM Hb A1c CAPILLARY CONTROLS (2)

IVD Class CNot specifiedOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: sebia
Manufacturer SRN: FR-MF-000003520
UDI-DI: 03607360047682
Basic UDI-DI: 3607364767BUFW
Reference: 4768
EMDN: W0101050205
EMDN description: DIABETES CONTROLS
First on market country: -
Authorised representative: -
Last updated: 02.07.2026 03:34

Manufacturer products View details

Multichem MS VItD

Multichem MS VitD

IVD Class BIVDR 2017/746On the marketHuman tissuesProfessional testing

Manufacturer: Techno-path Manufacturing Ltd.
Manufacturer SRN: IE-MF-000001822
UDI-DI: 05391523442367
Basic UDI-DI: 539152344CHEM155L
Reference: 09922555190
EMDN: W0101050299
EMDN description: SPECIFIC CONTROLS (CC) - OTHER
First on market country: Ireland
Authorised representative: -
Last updated: 02.07.2026 03:14

Manufacturer products View details

HbA1c CONTROL

HbA1c

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Medicon Hellas SA
Manufacturer SRN: GR-MF-000013625
UDI-DI: 05204309162215
Basic UDI-DI: 5204309000026NU
Reference: 1578-1057
EMDN: W0101050299
EMDN description: SPECIFIC CONTROLS (CC) - OTHER
First on market country: Greece
Authorised representative: -
Last updated: 02.07.2026 02:53

Manufacturer products View details

TOTAL ANTIOXIDANT STATUS (TAS CONTROL)

TOTAL ANTIOXIDANT STATUS CONTROL

IVD Class BIVDR 2017/746On the marketNo EU repHuman tissuesKitProfessional testingReagent

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273204728
Basic UDI-DI: 50552732BTTATSS111Y8
Reference: NX2331
EMDN: W0101050299
EMDN description: SPECIFIC CONTROLS (CC) - OTHER
First on market country: Northern Ireland
Authorised representative: -
Last updated: 02.07.2026 01:44

Manufacturer products View details

i-Smart Electrolyte Quality Control

IVD Class BIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: i-SENS, Inc.
Manufacturer SRN: KR-MF-000009173
UDI-DI: 08806712905730
Basic UDI-DI: 8806712POCEQC001HW
Reference: POCEQC001
EMDN: W0101050204
EMDN description: ELECTROLYTE CONTROLS
First on market country: -
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 01.07.2026 06:37

Manufacturer products Authorised representative products Authorised representative actors View details

Serachem HbA1c

HbA1c

IVD Class CIVDR 2017/746On the marketDirect markingKitMicrobial substancesProfessional testingReagent

Manufacturer: Instrumentation Laboratory SpA
Manufacturer SRN: IT-MF-000009277
UDI-DI: 08426951410835
Basic UDI-DI: 84307930553384W
Reference: 0018167500
EMDN: W0101050205
EMDN description: DIABETES CONTROLS
First on market country: Italy
Authorised representative: -
Last updated: 30.06.2026 15:25

Manufacturer products View details

Ammonia Controls

Ammonia

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

Manufacturer: SENTINEL CH. S.p.A.
Manufacturer SRN: IT-MF-000012556
UDI-DI: 08058056682895
Basic UDI-DI: 805805668CIAMMO01ZZ018NQK
Reference: 6K89-20
EMDN: W0101050204
EMDN description: ELECTROLYTE CONTROLS
First on market country: Italy
Authorised representative: -
Last updated: 30.06.2026 15:13

Manufacturer products View details

Controls

CO-Oximeter Control Level 3