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Biochemistry Analyzer
EUDAMEDClass A (EU MDR)
Ref WHY7000DModel WHY5000D, WHY5000B, WHY8000D, WHY8000D VET, WHY6000D, WHY7000D, D-06, D-B6, D-C6, D-D6, A6, B6, C6, WHYA7, WHYA8Ref D-C6Ref WHY5000BRef D-B6Ref C6Ref B6Ref WHY8000D VETRef D-D6
Identity
- Trade Name
- Biochemistry Analyzer EUDAMED
- Device Name
- Biochemistry Analyzer EUDAMED
- Model / Reference
- WHY5000D, WHY5000B, WHY8000D, WHY8000D VET, WHY6000D, WHY7000D, D-06, D-B6, D-C6, D-D6, A6, B6, C6, WHYA7, WHYA8 EUDAMEDWHY7000D EUDAMEDD-C6 EUDAMEDWHY5000B EUDAMEDD-B6 EUDAMEDC6 EUDAMEDB6 EUDAMEDWHY8000D VET EUDAMEDD-D6 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977226450169 EUDAMED06977226450190 EUDAMED06977226450121 EUDAMED06977226450183 EUDAMED06977226450237 EUDAMED06977226450220 EUDAMED06977226450145 EUDAMED06977226450206 EUDAMED
- Basic UDI-DI
- 697722645BTBA01L5 EUDAMED
- EMDN Code
- W0299 IVD INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
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
Biochemistry Analyzer by Nanjing Poweam Medical 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 | 697722645BTBA01L5 | Class A | Active |
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Manufacturer
- Manufacturer
- Nanjing Poweam Medical Co., Ltd
- EUDAMED SRN
- CN-MF-000040207
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (8)
- EUDAMED 554a185b-c8c7-4d7e-9cd8-e9d59601737d 61 fields · synced Oct 6, 2026
- EUDAMED b78d073f-73cc-4ec3-be8c-273bb1f632a0 61 fields · synced May 18, 2026
- EUDAMED eec00dac-503a-4c6b-a27a-ad0c06e392e4 61 fields · synced May 18, 2026
- EUDAMED 080922b5-6032-44a9-b5c9-2f65c7e128bb 61 fields · synced May 18, 2026
- EUDAMED e067391c-a010-4639-b3f4-02591b0a744e 61 fields · synced May 19, 2026
- EUDAMED b5f7a12c-93c2-462b-9847-830a52cee471 61 fields · synced May 19, 2026
- EUDAMED 9016c1ec-b413-4f24-8003-eeff1318053c 61 fields · synced May 19, 2026
- EUDAMED 009232bf-f9f1-497b-925d-1395cab6ffe2 61 fields · synced May 19, 2026