BlueTech
by Top Glove Sdn. Bhd. EUDAMED
Active
Ref MLNBL-XS, MABLUBM, MABLUMXL, MABLUBXS, MABLUBL, MABLUMS, MABLURXS, MABLUBS, MLNBL-XL, MABLUNXS, MABLURS, MABLURXL, MABLURL, MABLUMXS
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number955760101080G4 | Date1 Apr 2022 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Certificates
No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.
Specification
- Device Name
- Latex Examination Powder Free GloveNitrile Examination Powder Free Gloves
- Model / Reference
- MLNBL-XS, MABLUBM, MABLUMXL, MABLUBXS, MABLUBL, MABLUMS, MABLURXS, MABLUBS, MLNBL-XL, MABLUNXS, MABLURS, MABLURXL, MABLURL, MABLUMXS
- Primary DI / UDI-DI
- 09551004376925, 09551004339746, 09551004339869, 09551004339722, 09551004339753, 09551004339838, 09551004339623, 09551004339739, 09551004376963, 09551004339920, 09551004339630, 09551004339661, 09551004339654, 09551004339821, 09551004347864
- Basic UDI-DI
- 955760101080G4, 955760101940H5
- EMDN Code
- T010201, T01020204
- Device Class
- Class I
- Market of Registration
- Romania
Manufacturer details
- EUDAMED SRN
- MY-MF-000009690
- Authorised representative
- Ulma International GmbH DE-AR-000010015
Other devices from Top Glove 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