TypeII with earloop
by Anhui Tiankang Medical Technology Co., Ltd.
Ref TKMFM005
TypeII with earloop (TKMFM005) is a Class I device made by Anhui Tiankang Medical Technology Co., Ltd., registered in EUDAMED on 4 Nov 2026 (Basic UDI-DI 69348415000056Q), active as of 7 Nov 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 | Number69348415000056Q 06934841516052 | Date4 Nov 2026 | StatusActive |
Official records
- EUDAMED public site 69348415000056Q
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- Withdrawn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
- Model / reference
- TKMFM005
- Primary DI / UDI-DI
- 06934841516052
- Basic UDI-DI
- 69348415000056Q
- Direct marketing DI
- 06934841516052
- EMDN code
- T020604 Medical use face masks, type II and iir
- Device class
- Class I
- System or procedure pack
- Procedure pack which is a device in itself
- EU registration type
- Standard device
- EU market of registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000017064
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
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