Dm
by Guilin Kevin Peter Technology Co., Ltd. 21 variants
Part of a family of 44 devices: see the family page
Ref Loupe4044s
Dm (Loupe4044s) is a Class I device made by Guilin Kevin Peter Technology Co., Ltd., registered in EUDAMED on 4 Jun 2026 (Basic UDI-DI 69753843314YV), active as of 25 Oct 2026.
Active
CE MDR
Valid until
No date given
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number69753843314YV 06975384339623 | Date4 Jun 2026 | StatusActive |
Official records
- EUDAMED public site 69753843314YV
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- Withdrawn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
- Surgical Loupes
- Model / reference
- Loupe4044s
- Primary DI / UDI-DI
- 06975384339623
- Basic UDI-DI
- 69753843314YV
- EMDN code
- L0316 Helmets and binocular glasses for surgeons
- Device class
- Class I
- EU registration type
- Standard device
- EU market of registration
- Northern Ireland
Manufacturer details
- EUDAMED SRN
- CN-MF-000022934
- Authorised representative
- MedNet EC-REP C IIb GmbH DE-AR-000011194
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