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EUDAMEDClass IIb (EU MDR)
Ref 91962UCRef 91962AXRef 91962SLRef 91962CQRef 91962GMRef 91962HU
Identity
- Trade Name
- REFRESH CONTACTS EUDAMED
- Device Name
- Contact Lens Lubricating and Rewetting Solutions EUDAMED
- Model / Reference
- 91962UC EUDAMED91962AX EUDAMED91962SL EUDAMED91962CQ EUDAMED91962GM EUDAMED91962HU EUDAMED
Identifiers
- Primary DI / UDI-DI
- 10840228300226 EUDAMED10840228300127 EUDAMED10840228300219 EUDAMED10840228300134 EUDAMED10840228300158 EUDAMED10840228300202 EUDAMED
- Basic UDI-DI
- 0840228300044H EUDAMED
- Direct Marketing DI
- 10840228300226 EUDAMED10840228300127 EUDAMED10840228300219 EUDAMED10840228300134 EUDAMED10840228300158 EUDAMED10840228300202 EUDAMED
- EMDN Code
- Q02030204,Q02030206,Q02030299,Q0299 EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Slovenia EUDAMEDSpain EUDAMEDCroatia EUDAMEDLiechtenstein EUDAMEDHungary 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
Refresh Contacts 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 (6)
- EUDAMED 81279838-dd1f-4590-8418-d8288e042c70 61 fields · synced Jul 30, 2026
- EUDAMED e8eac5f9-71e6-462b-916c-8a5c8771f4bd 61 fields · synced May 17, 2026
- EUDAMED 40e0a995-77a7-48c8-a7a2-0b277e9cbb78 61 fields · synced May 17, 2026
- EUDAMED 1933cab4-ce0a-4946-93e2-9cb148e09177 61 fields · synced May 17, 2026
- EUDAMED 87debb32-9b1b-42c2-bc5c-9530c5c3969d 61 fields · synced May 18, 2026
- EUDAMED 6b75f3a5-6ee8-464f-9de5-19adf7d2aee3 61 fields · synced May 18, 2026