Examination Glove Nitrile
by Qube Medical Products Sdn Bhd EUDAMED
Active
Ref 9551012524028, NBR12PFFT60BSC
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | NumberB-955101252NBR35RB100SSP | Date22 May 2025 | StatusActive |
| European Union | CE/MDD | NumberB-955101252NBR35RB100SSP | Date22 May 2025 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR, CE/MDD Active
Specification
- Trade Name
- Qube
- Device Name
- Examination Glove Nitrile12 Inch Powder Free Nitrile Glove, Finger Textured, Regular Blue, Single Chlorinated, 6.0g, Size M, Outer Carton Box12 Inch Powder Free Nitrile Glove, Finger Textured, Regular Blue, Single Chlorinated, 6.0g
- Model / Reference
- 9551012524028, NBR12PFFT60BSC
- Primary DI / UDI-DI
- D-955101252NBR35RB100SSP, 09551028344726, 09551028344719, 09551028344696, 09551028344689, 09551028344658, 09551028344733, 09551028344740, 09551028344665, 09551028344672, 09551028344702
- Basic UDI-DI
- B-955101252NBR35RB100SSP, 955102834QBNBRRB60MCTNTG, 955102834QUBENBRRB60AQ
- 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