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HbA1c Analyzer
EUDAMEDClass A (EU MDR)
Ref TH7000AModel TH6000，THX6000，TH7000A，TH7000B
Identity
- Trade Name
- HbA1c Analyzer EUDAMED
- Device Name
- HbA1c Analyzer EUDAMED
- Model / Reference
- TH6000，THX6000，TH7000A，TH7000B EUDAMEDTH7000A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977226450282 EUDAMED
- Basic UDI-DI
- 697722645BTHA02MH 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
HbA1c 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 | 697722645BTHA02MH | 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 (1)
- EUDAMED 7c3f94fa-445f-4bde-8f74-3572f8b07ce7 61 fields · synced Oct 6, 2026