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Reaction sample well
EUDAMEDClass A (EU MDR)
Ref BTK-E02-B48-20-00Model BTK-8-B10-10-00, BTK-8-B8-10-00, BTK-8-B4-10-00, BTK-8-B4-20-00, BTK-E04-B1-20-00, BTK-E04-B1-25-00, BTK-E04-B1-30-00, BTK-E04-B1-40-00, BTK-E02-B48-20-00, BTK-E02-B48-25-00"
Identity
- Device Name
- Reaction sample well EUDAMED
- Model / Reference
- BTK-8-B10-10-00, BTK-8-B8-10-00, BTK-8-B4-10-00, BTK-8-B4-20-00, BTK-E04-B1-20-00, BTK-E04-B1-25-00, BTK-E04-B1-30-00, BTK-E04-B1-40-00, BTK-E02-B48-20-00, BTK-E02-B48-25-00" EUDAMEDBTK-E02-B48-20-00 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974541565349 EUDAMED
- Basic UDI-DI
- 697454156014L4 EUDAMED
- EMDN Code
- W0599 IVD GENERAL USE CONSUMABLE DEVICES - 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
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Reaction sample well by Bioteke Corporation (Wuxi) 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 | 697454156014L4 | Class A | Active |
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Manufacturer
- Manufacturer
- BioTeke Corporation（Wuxi）Co., Ltd
- EUDAMED SRN
- CN-MF-000007517
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED a052d4e3-2821-46c2-981e-1f24e502de5a 61 fields · synced Jun 20, 2026