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Cell culture
EUDAMEDClass A (EU MDR)
Ref C000060WModel C000035，C000060，C000100，C000035W，C000060W，C000100W，C001035，C001060，C001100，C001035W，C001060W，C001100W，C010001，etc
Identity
- Device Name
- Cell culture EUDAMED
- Model / Reference
- C000035，C000060，C000100，C000035W，C000060W，C000100W，C001035，C001060，C001100，C001035W，C001060W，C001100W，C010001，etc EUDAMEDC000060W EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06979006042342 EUDAMED
- Basic UDI-DI
- 697900604CC0018F EUDAMED
- EMDN Code
- W0503040102 CELL AND TISSUE CULTURES, DISHES 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
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Cell culture by Hangzhou Agen Biotechnology 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 | 697900604CC0018F | Class A | Active |
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Manufacturer
- Manufacturer
- Hangzhou Agen Biotechnology Co Ltd
- EUDAMED SRN
- CN-MF-000049623
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED ee2a63a5-e8d2-47c2-a513-20ac7be78a9d 61 fields · synced Jun 18, 2026