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Cowingene Sample Diluent Reagent
EUDAMEDClass A (EU MDR)
Ref CW09021WRef CW06021Z
Identity
- Trade Name
- Cowingene Sample Diluent Reagent EUDAMED
- Device Name
- Cowingene Sample Diluent Reagent EUDAMED
- Model / Reference
- CW09021W EUDAMEDCW06021Z EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977537461786 EUDAMED06977537461748 EUDAMED
- Basic UDI-DI
- 697753746CW06RC EUDAMED
- EMDN Code
- W0599 IVD GENERAL USE CONSUMABLE DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Cowingene Sample Diluent Reagent by Taizhou Cowingene Biotech Co., Ltd. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 697753746CW06RC | Class A | Active |
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Manufacturer
- Manufacturer
- Taizhou Cowingene Biotech Co., Ltd.
- EUDAMED SRN
- CN-MF-000042619
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (2)
- EUDAMED 6cee4bb7-8215-4eeb-94f1-809786826bbe 61 fields · synced Jul 11, 2026
- EUDAMED 8045d338-1fba-413b-a588-e31a7118dd27 61 fields · synced May 17, 2026