Happyhands
by Supermax Glove Manufacturing Sdn Bhd 10 variants
Ref XL
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 | Number955100345122AZ 09551003458721 | Date7 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- Withdrawn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 Gloves
- Model / Reference
- XL
- Primary DI / UDI-DI
- 09551003458721
- Basic UDI-DI
- 955100345122AZ
- EMDN Code
- T010201 Latex examination / treatment gloves
- Device Class
- Class I
- EU market of registration
- Italy
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 (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