Max-Bold
by Maxter Glove Manufacturing Sdn Bhd 7 variants
Ref M, L, XL, S
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 | Number955500211636CP | Date27 Dec 2021 | 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- Withdrawn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
- Device Name
- Powdered Latex Examination GlovesPowder Free Nitrile Examination Gloves
- Model / Reference
- M, L, XL, S
- Primary DI / UDI-DI
- 09555002118907, 09555002118969, 09555002118976, 09555002118891, 09555002119690, 09555002118143, 09555002119713, 09555002119706, 09555002119683, 09555002118945, 09555002118952, 09555002118167, 09555002118174, 09555002118914
- Basic UDI-DI
- 955500211636CP, 955500211638CT
- EMDN Code
- T010201, T01020204
- Device Class
- Class I
- EU market of registration
- GermanyGreecePoland
Manufacturer details
- EUDAMED SRN
- MY-MF-000016719
- Authorised representative
- Obelis s.a. BE-AR-000000106
Other devices from Maxter Glove Manufacturing Sdn Bhd
Properties
Other properties (12)
- Sterile: No
- 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