Identity
- Trade Name
- CELLUFRESH EUDAMED
- Device Name
- Contact Lens Lubricating and Rewetting Solutions EUDAMED
- Model / Reference
- 92466EW EUDAMED92143IT EUDAMED
Identifiers
- Primary DI / UDI-DI
- 10840228300431 EUDAMED10840228300400 EUDAMED
- Basic UDI-DI
- 0840228300044H EUDAMED
- Unit of Use DI
- 20840228300438 EUDAMED
- Direct Marketing DI
- 10840228300400 EUDAMED
- EMDN Code
- Q02030204,Q02030206,Q02030299,Q0299 EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany EUDAMEDItaly EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
Yes
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Cellufresh by Allergan Sales, LLC — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0840228300044H | Class IIb | Active |
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Manufacturer
- Manufacturer
- Allergan Sales, LLC
- EUDAMED SRN
- US-MF-000001517
- Authorised Representative
- Allergan Pharmaceuticals International Limited IE-AR-000000650
Sources (2)
- EUDAMED faa5b9a8-6711-4bb4-87e0-5d51ff54df60 61 fields · synced Jul 14, 2026
- EUDAMED 6bc31c11-d496-4aaf-b15d-66023e2110e3 61 fields · synced May 18, 2026