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Microplate Reader
EUDAMEDClass A (EU MDR)
Ref BGMR-1000SRef BGMR-2000BRef BGMR-2000ARef BGMR-1000
Identity
- Trade Name
- Microplate Reader EUDAMED
- Device Name
- Microplate Reader EUDAMED
- Model / Reference
- BGMR-1000S EUDAMEDBGMR-2000B EUDAMEDBGMR-2000A EUDAMEDBGMR-1000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16975412637018 EUDAMED16975412637032 EUDAMED16975412637025 EUDAMED16975412637001 EUDAMED
- Basic UDI-DI
- 697541263700KG EUDAMED
- Direct Marketing DI
- 16975412637018 EUDAMED16975412637032 EUDAMED16975412637025 EUDAMED16975412637001 EUDAMED
- EMDN Code
- W05039099 DEVICES FOR SAMPLES ANALYSES - 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
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 Hangzhou Bio-gener Technology 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 | 697541263700KG | Class A | Active |
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Manufacturer
- Manufacturer
- Hangzhou Bio-gener Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000027988
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (4)
- EUDAMED cbb37de5-72f8-444a-8b1c-f0da2648bbf0 61 fields · synced Sep 18, 2026
- EUDAMED 41e058f6-ba97-4b8a-bc76-9c9136dfb73a 61 fields · synced May 18, 2026
- EUDAMED 3e3dde63-acd9-4bc3-80fe-e2d7d0e2dc93 61 fields · synced May 18, 2026
- EUDAMED fd1f8377-9e7e-4480-9913-e8857dd41cc3 61 fields · synced May 19, 2026