sempermed safe+
by HARPS Investment Asia Pte. Ltd. 3 variants
Ref 3000016030Model Non sterile, single use, powder free, nitrile, examination glove, ambidextrous, regular blue, extended cuff
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 | Number9001570NOF-065RB-N-869 09001570550590 | Date12 Mar 2026 | 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- Withdrawn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
- Model / Reference
- Non sterile, single use, powder free, nitrile, examination glove, ambidextrous, regular blue, extended cuff, 3000016030
- Primary DI / UDI-DI
- 09001570550590
- Basic UDI-DI
- 9001570NOF-065RB-N-869
- Unit of Use DI
- 09001570553249
- EMDN Code
- T01020204 Nitrile examination / treatment gloves
- Device Class
- Class I
- EU market of registration
- Austria
Manufacturer details
- EUDAMED SRN
- SG-MF-000001645
- Authorised representative
- HARPS Europe GmbH AT-AR-000040870
Other devices from HARPS Investment Asia Pte. 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