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Consumables for Nucleic Acid Extraction
EUDAMEDClass A (EU MDR)
Ref AU1001-5Model AU1001-2,AU1001-3,AU1001-5
Identity
- Device Name
- Consumables for Nucleic Acid Extraction EUDAMED
- Model / Reference
- AU1001-2,AU1001-3,AU1001-5 EUDAMEDAU1001-5 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974541565257 EUDAMED
- Basic UDI-DI
- 697454156015L6 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
Consumables for Nucleic Acid Extraction 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 | 697454156015L6 | 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 59cab970-f30f-4406-a78e-cc24d1ed8e41 61 fields · synced Jul 20, 2026