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by Allergan Sales, LLC 8 variants
Ref 91962GM
Expiring
CE MDR
Valid until
6 May 2027
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number0840228300044H 10840228300158 | Date25 Apr 2025 | StatusActive |
Certificates
- 3829879CE01 Expiring
Quality management system EU MDR
- Certifier
- DEKRA Certification B.V. 0344
- Issued
- 6 May 2022
- Expires
- 6 May 2027
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Expiring
Specification
- Device Name
- Contact Lens Lubricating and Rewetting Solutions
- Model / Reference
- 91962GM
- Primary DI / UDI-DI
- 10840228300158
- Basic UDI-DI
- 0840228300044H
- Direct Marketing DI
- 10840228300158
- EMDN Code
- Q02030204, Q02030206, Q02030299, Q0299
- Device Class
- Class IIb
- EU market of registration
- Liechtenstein
Manufacturer details
- EUDAMED SRN
- US-MF-000001517
- Authorised representative
- Allergan Pharmaceuticals International Limited IE-AR-000000650
Other devices from Allergan Sales, LLC
Properties
Other properties (10)
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Measuring Function: No
- Incorporates Medicinal Product: No