Ophthalmic Drape
by Exact Medical Manufacturing, Inc
Ref DEF5669Model Ophthalmic Drape
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697508570SD21ME 06975085709817 | Date4 Aug 2023 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Model / Reference
- Ophthalmic Drape, DEF5669
- Primary DI / UDI-DI
- 06975085709817
- Basic UDI-DI
- 697508570SD21ME
- EMDN Code
- T02010101 Incision drapes, without antibacterial agent
- Device Class
- Class I
- EU market of registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- CN-MF-000001406
- Authorised representative
- Exact Medical Manufacturing B.V. NL-AR-000000452
Other devices from Exact Medical Manufacturing, Inc
Properties
Other properties (12)
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No