Polycare France
by Wuhan Zonsen Medical Products Co., Ltd 5 variants
Ref PK-1
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 | Number697199986ZPG5P | Date23 Jun 2025 | 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- Withdrawn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
- Patient gownDoctor capShoe coverExamination underpants
- Model / Reference
- PK-1
- Primary DI / UDI-DI
- 06976128166963, 06976128166390, 06976128169827, 06976128165119
- Basic UDI-DI
- 697199986ZPG5P, 697199986ZDC4B, 697199986ZSC5Q, 697612816ZEUVR
- EMDN Code
- T0205, T0207, T0208, T0299
- Device Class
- Class I
- EU market of registration
- France
Manufacturer details
- EUDAMED SRN
- CN-MF-000008034
- Authorised representative
- Lotus NL B.V. NL-AR-000000121
Other devices from Wuhan Zonsen Medical Products Co., Ltd
See all devices from Wuhan Zonsen Medical Products 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