Cap
by Hygiea Medical Technology (Beijing) Co., Ltd.
Ref HMMCBU01, HMMCGN01, HMMCYL01, HMMCWT01, HMMCBK01, HMMCRD01, HMBCBU01, HMBCGN01, HMBCYL01, HMBCWT01, HMBCBK01, HMBCRD01Model HMMCBU01; HMMCGN01; HMMCWT01; HMBCBU01; HMBCGN01; HMBCWT01; HMBHBU01
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 | Number697633971CapYS 16976339710341 | Date5 Apr 2024 | 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- Withdrawn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
- Caps
- Model / Reference
- HMMCBU01, HMMCGN01, HMMCWT01, HMBCBU01, HMBCGN01, HMBCWT01, HMBHBU01, HMMCYL01, HMMCBK01, HMMCRD01, HMBCYL01, HMBCBK01, HMBCRD01
- Primary DI / UDI-DI
- 16976339710341
- Basic UDI-DI
- 697633971CapYS
- EMDN Code
- T0207 Caps and headwear (excluding personal protective equipment - PPE)
- Device Class
- Class I
- EU market of registration
- Croatia
Manufacturer details
- EUDAMED SRN
- CN-MF-000041007
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Hygiea Medical Technology (Beijing) Co., Ltd.
See all devices from Hygiea Medical Technology (Beijing) Co., 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