semperguard skySense black
by HARPS Investment Asia Pte. Ltd. 5 variants
Ref 3000016470Model Non sterile, single use, powder free, nitrile, examination glove, ambidextrous, black
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-032BK-N-3X3 09001570554741 | Date4 May 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- Withdrawn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, black, 3000016470
- Primary DI / UDI-DI
- 09001570554741
- Basic UDI-DI
- 9001570NOF-032BK-N-3X3
- Unit of Use DI
- 09001570554772
- 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