JFA Nitrile Gloves - Blue, Large - Insert for FAK
by Shandong Blue Sail Health Technology Co., Ltd
Ref JF1185Model EM-0102
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 | Number697544335EM0102156286L4 05060924462105 | Date27 Mar 2023 | 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- Withdrawn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
- Disposable Nitrile Examination Gloves, Powder Free
- Model / Reference
- EM-0102, JF1185
- Primary DI / UDI-DI
- 05060924462105
- Basic UDI-DI
- 697544335EM0102156286L4
- Direct Marketing DI
- 05060924462105
- EMDN Code
- T01020204 Nitrile examination / treatment gloves
- Device Class
- Class I
- EU market of registration
- Ireland
Manufacturer details
- EUDAMED SRN
- CN-MF-000020659
- Authorised representative
- Lotus NL B.V. NL-AR-000000121
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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