semperguard skySense
by HARPS Investment Asia Pte. Ltd. EUDAMED
Active
Ref 3000015831Model Non sterile, single use, powder free, nitrile, examination glove, ambidextrous, regular blue
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number9001570NOF-032RB-N-32K | Date4 May 2026 | 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- Withdrawn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
- Model / Reference
- Non sterile, single use, powder free, nitrile, examination glove, ambidextrous, regular blue, 3000015831
- Primary DI / UDI-DI
- 09001570549297
- Basic UDI-DI
- 9001570NOF-032RB-N-32K
- Unit of Use DI
- 09001570556585
- EMDN Code
- T01020204 Nitrile examination / treatment gloves
- Device Class
- Class I
- 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