Identity
- Trade Name
- AmnioMAX II Complete EUDAMEDAmnioMAX™-II Complete Medium FDA UDI
- Generic Name
- Cell culture medium IVD FDA UDI
- Device Name
- AmnioMAX II Complete Medium EUDAMED
- Model / Reference
- 11269-016 EUDAMED11269016 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10190302001762 EUDAMEDFDA UDI
- Basic UDI-DI
- 0190302TCF00003664Q EUDAMED
- FDA Product Code
- KIT FDA UDI
- EMDN Code
- W01030701 CHROMOSOME CULTURE KITS / REAGENTS EUDAMED
- GMDN Term
- Cell culture medium IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 864.2220 FDA UDI
- Market of Registration
- Austria 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
Yes
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
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
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
AmnioMAX II Complete by Life Technologies Corporation ( Grand Island ) — 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 | 0190302TCF00003664Q | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- Life Technologies Corporation ( Grand Island )
- EUDAMED SRN
- US-MF-000029796
- Authorised Representative
- Life Technologies Europe B.V. NL-AR-000021890
Sources (2)
- EUDAMED e7a311de-7537-46dc-84e0-c7279c198740 61 fields · synced Jul 27, 2026
- FDA UDI c2f6b02f-b9bb-4607-b04d-09b1ffaeb8bf 32 fields · synced May 30, 2026