Maxter
by Supermax Glove Manufacturing Sdn Bhd 6 variants
Ref 8.0
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 | Number955100345125B7 09551003458516 | Date19 Feb 2025 | 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- Withdrawn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
- Device Name
- Powdered Latex Surgical Gloves
- Model / Reference
- 8.0
- Primary DI / UDI-DI
- 09551003458516
- Basic UDI-DI
- 955100345125B7
- EMDN Code
- T01010101 Powdered latex surgical gloves
- Device Class
- Class IIa
- EU market of registration
- Croatia
Manufacturer details
- EUDAMED SRN
- MY-MF-000016722
- Authorised representative
- Obelis s.a. BE-AR-000000106
Other devices from Supermax Glove Manufacturing Sdn Bhd
Properties
Other properties (11)
- Implantable: No
- Reusable: 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