Identity
- Trade Name
- FREND AP EUDAMEDFDA UDI
- Generic Name
- Heating block IVD FDA UDI
- Device Name
- FREND AP EUDAMED
- Model / Reference
- FREND AP EUDAMEDF10AP EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809317540467 EUDAMEDFDA UDI
- Basic UDI-DI
- 880931754FRENDAPWX EUDAMED
- FDA Product Code
- JRG FDA UDI
- EMDN Code
- W02069080 VARIOUS SAMPLE PROCESSING INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Heating block IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 862.2050 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Frend Ap by NanoEnTek, Inc. — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 880931754FRENDAPWX | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- NanoEntek, Inc.
- EUDAMED SRN
- KR-MF-000021903
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (2)
- EUDAMED 52f5cac4-1889-4d50-8fce-35aeadb491f8 61 fields · synced Jul 22, 2026
- FDA UDI 9d239ab8-6536-42e2-9bca-8df62b42b044 32 fields · synced May 30, 2026