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Microplate Reader
EUDAMEDClass A (EU MDR)
Ref WHY101SModel WHY101S, WHY101ST, WHYM201, WHYM301Ref WHYM201Ref WHY101STRef WHYM301
Identity
- Trade Name
- Microplate Reader EUDAMED
- Device Name
- Microplate Reader EUDAMED
- Model / Reference
- WHY101S, WHY101ST, WHYM201, WHYM301 EUDAMEDWHY101S EUDAMEDWHYM201 EUDAMEDWHY101ST EUDAMEDWHYM301 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977226450411 EUDAMED06977226450435 EUDAMED06977226450428 EUDAMED06977226450442 EUDAMED
- Basic UDI-DI
- 697722645BTMR01R7 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
Yes
EUDAMED
New Device
No
EUDAMED
Microplate Reader 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 | 697722645BTMR01R7 | 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 (4)
- EUDAMED f40a4d5c-9fbc-4f40-ae7c-9b0e325b0db8 61 fields · synced Oct 6, 2026
- EUDAMED e8cc6a0a-285e-4f9f-8c80-1eb09088544e 61 fields · synced May 17, 2026
- EUDAMED 013ab597-0556-465b-9dac-2d84dab7229e 61 fields · synced May 18, 2026
- EUDAMED b2edd429-e49f-4626-918b-36d49176811b 61 fields · synced May 18, 2026