BioTeke
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- BioTeke FDA UDI
- Generic Name
- Nucleic acid sample preparation instrument IVD FDA UDI
- Device Name
- Automated Nucleic Acid Extraction System EUDAMED
- Model / Reference
- AU1001-96 EUDAMEDFDA UDIAU1001,AU1001S,AU1001-96 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974541565059 EUDAMED06974541563673 FDA UDI
- Basic UDI-DI
- 697454156003KX EUDAMED
- FDA Product Code
- JJH FDA UDI
- EMDN Code
- W02050116 NUCLEIC ACID TESTING INTEGRATED EXTRACTION /AMPLIFICATION /DETECTION SYSTEMS EUDAMED
- GMDN Term
- Nucleic acid sample preparation instrument IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 862.2310 FDA UDI
- Market of Registration
- Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Contains Latex
No
Human Tissues
No
Animal Tissues
No
Microbial Substances
No
Reagent
No
Self Testing
No
Near-Patient Testing
No
Professional Testing
No
Companion Diagnostics
No
Surgical Instrument
Yes
New Device
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
Yes
Manufacturing Date
Yes
Category: Nucleic acid sample preparation instrument IVD
BioTeke by Bioteke Corporation (Wuxi) Co., Ltd. — Class I — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Nucleic acid sample preparation instrument IVD.
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Authorization Coverage (2 countries)
Regulatory Authorizations
IVDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Bioteke Corporation (Wuxi) Co., Ltd.
Sources (2)
- FDA UDI d7ae85f4-f8e7-47e0-86e7-cc8da9b71d2a 32 fields · synced Jul 11, 2026
- EUDAMED 9b04aa07-f1e3-4cba-8163-b8066af50ef2 61 fields · synced Jul 11, 2026