Handheld Occluder for Eye Examination
Ref BM-12001
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number890620083OCDLS 08906200830510 | Date20 Jul 2026 | StatusActive |
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Eye Occluder
- Model / Reference
- BM-12001
- Primary DI / UDI-DI
- 08906200830510
- Basic UDI-DI
- 890620083OCDLS
- EMDN Code
- Q010401 Orthodontic face bows
- Device Class
- Class I
- EU market of registration
- Austria
Manufacturer details
- EUDAMED SRN
- IN-MF-000048187
- Authorised representative
- Ellecom GmbH DE-AR-000012869
From the manufacturer
Manufacturer's product page: 10w LED Surgical Headlight for ENT, Dental and Medical Examination
Other devices from Basch Medical Pvt Ltd
Properties
Other properties (13)
- Sterile: No
- 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