Parmadis
by Zibo Blue Sail Health Technology Co., Ltd. EUDAMED
Active
Ref FI1083T8Model EM0104
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697521922EM0104147176FR | Date26 Sep 2024 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Certificates
No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.
Specification
- Device Name
- Disposable Polyurethane Examination Gloves, Powder Free
- Model / Reference
- EM0104, FI1083T8
- Primary DI / UDI-DI
- 06975219220447
- Basic UDI-DI
- 697521922EM0104147176FR
- Direct Marketing DI
- 06975219220447
- EMDN Code
- T01020204 Nitrile examination / treatment gloves
- Device Class
- Class I
- Market of Registration
- France
Manufacturer details
- EUDAMED SRN
- CN-MF-000023102
- Authorised representative
- Lotus NL B.V. NL-AR-000000121
Other devices from Zibo Blue Sail Health Technology Co., Ltd.
See all devices from Zibo Blue Sail Health Technology 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