Skytec
by Globus (Shetland) Ltd United Kingdom EUDAMED
Ref SKG00428DDModel TX428 EMDN T01020204
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number5060855886SKY428EX | Date28 Nov 2023 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Skytec NX428 Blue Nitrile Disposable Gloves
- Model / Reference
- TX428, SKG00428DD
- Primary DI / UDI-DI
- 05060855886421
- Basic UDI-DI
- 5060855886SKY428EX
- EMDN Code
- T01020204 Nitrile examination / treatment gloves
- Device Class
- Class I
- Market of Registration
- Ireland
Manufacturer details
- EUDAMED SRN
- GB-MF-000007384
- Authorised representative
- Globus EMEA Ltd IE-AR-000002785
Other devices from Globus (Shetland) Ltd
Properties & raw data
Show properties, registry sources and raw records
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
Sources (1)
- EUDAMED 64123a34-a885-4dbf-98db-8a81ceab52c4