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Infection Guard, Nitril
EUDAMEDClass I (EU MDR)
Ref QM5218101YNP-SRef QM5218101YNP-LRef QM5218101YNP-XL
Identity
- Trade Name
- Infection Guard, Nitril EUDAMED
- Device Name
- Powder Free On Line Chlorinated Nitrile Examination Gloves EUDAMED
- Model / Reference
- QM5218101YNP-S EUDAMEDQM5218101YNP-L EUDAMEDQM5218101YNP-XL EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09551013870834 EUDAMED09551013870810 EUDAMED09551013870865 EUDAMED09551013870919 EUDAMED
- Basic UDI-DI
- 955101387NBRM3 EUDAMED
- EMDN Code
- T01020204 NITRILE EXAMINATION / TREATMENT GLOVES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Infection Guard, Nitril by Yty Industry Sdn Bhd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 955101387NBRM3 | Class I | Active |
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Manufacturer
- Manufacturer
- Yty Industry Sdn Bhd
- EUDAMED SRN
- MY-MF-000009643
- Authorised Representative
- mdi Europa GmbH DE-AR-000006218
Sources (4)
- EUDAMED 442f9fc3-f1d5-4079-b957-63b7ed56d0ef 61 fields · synced Jul 20, 2026
- EUDAMED a8e49029-2a5b-49e3-a7c2-81f81d14d617 61 fields · synced May 17, 2026
- EUDAMED fa708d0a-a7ab-4b89-9955-d366fcdc76bf 61 fields · synced May 19, 2026
- EUDAMED b5daf055-a27e-4415-8548-cd7602237875 61 fields · synced May 19, 2026