Profeel Dhd Pi
by WRP Asia Pacific Sdn. Bhd. 3 variants
Ref P3370-56, P3380-56, P3355-57, P3360-56, P3385-56, P3370-57, P3390-56, P3360-57, P3365-56, P3375-57
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number9557795PI-SG017Q | Date19 Nov 2024 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Trade Name
- Profeel Dhd PiProfeel Dhd Pi Sensitive
- Device Name
- Polyisoprene Surgical Gloves, Powder Free, Sterile
- Model / Reference
- P3370-56, P3380-56, P3355-57, P3360-56, P3385-56, P3370-57, P3390-56, P3360-57, P3365-56, P3375-57
- Primary DI / UDI-DI
- 09557795006263, 09557795006287, 09557795012479, 09557795006249, 09557795006294, 09557795012509, 09557795006300, 09557795012486, 09557795006256, 09557795012516
- Basic UDI-DI
- 9557795PI-SG017Q
- EMDN Code
- T01010203 Polyisopren surgical gloves
- Device Class
- Class IIa
- EU market of registration
- Austria
Manufacturer details
- EUDAMED SRN
- MY-MF-000004690
- Authorised representative
- REMESCO HANDELSGESMBH AT-AR-000002669
Other devices from WRP Asia Pacific Sdn. Bhd.
Properties
Other properties (12)
- 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