AAMedix
by Aamedix Glove Sdn Bhd 2 variants
Ref AA 11146-LTX-PModel Latex Powdered Examination Gloves
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 | Number9551015251114-PEU 00723860111463 | Date8 Mar 2023 | 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- Withdrawn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
- AAMedix Latex Powdered Examination Gloves
- Model / Reference
- Latex Powdered Examination Gloves, AA 11146-LTX-P
- Primary DI / UDI-DI
- 00723860111463
- Basic UDI-DI
- 9551015251114-PEU
- Direct Marketing DI
- 00723860111463
- EMDN Code
- T010201 Latex examination / treatment gloves
- Device Class
- Class I
- EU market of registration
- Greece
Manufacturer details
- EUDAMED SRN
- MY-MF-000025086
- Authorised representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Other devices from Aamedix Glove Sdn Bhd
Properties
Other properties (10)
- Sterile: No
- Implantable: No
- Reusable: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Measuring Function: No
- Incorporates Medicinal Product: No