Qube
by Qube Medical Products Sdn Bhd EUDAMED
Active
Ref NBR9PFFT30BSCModel NBR12PFFT70BLSC
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number955102834QUBENBRRB30AF | Date3 Aug 2026 | 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- Withdrawn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
- 9 Inch Powder Free Nitrile Glove, Finger Textured, Regular Blue, Single Chlorinated, 3.0g12 Inch Powder Free Nitrile Glove, Finger Textured, Black, Single Chlorinated, 7.0g
- Model / Reference
- NBR9PFFT30BSC, NBR12PFFT70BLSC
- Primary DI / UDI-DI
- 09551028341855, 09551028341879, 09551028341909, 09551028341893, 09551028341930, 09551028341862, 09551028342623, 09551028341916, 09551028341848, 09551028341886, 09551028341923
- Basic UDI-DI
- 955102834QUBENBRRB30AF, 955102834QUBENBRBLCK70D5
- EMDN Code
- T01020204 Nitrile examination / treatment gloves
- Device Class
- Class I
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- MY-MF-000022842
- Authorised representative
- Qube Integrated Europe GmbH DE-AR-000046698
Other devices from Qube Medical Products Sdn Bhd
Properties
Other properties (13)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: 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