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nitrylex sterile
EUDAMEDClass I (EU MDR)
Ref RC30081002_0016Ref RC30081004_0016
Identity
- Trade Name
- nitrylex sterile EUDAMED
- Device Name
- Sterile Synthetic Medical Examination Gloves Powder Free – Nitrile EUDAMED
- Model / Reference
- RC30081002_0016 EUDAMEDRC30081004_0016 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00806363503697 EUDAMED00806363503895 EUDAMED
- Basic UDI-DI
- 806363SNGFMU EUDAMED
- EMDN Code
- T01020204 NITRILE EXAMINATION / TREATMENT GLOVES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Poland EUDAMED
Clinical & Handling
Sterile
Yes
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
nitrylex sterile by Kanam Latex Industries Private Limited — 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 | 806363SNGFMU | Class I | Active |
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Manufacturer
- Manufacturer
- Kanam Latex Industries Private Limited
- EUDAMED SRN
- IN-MF-000022741
- Authorised Representative
- Amstermed B.V. NL-AR-000001971
Sources (2)
- EUDAMED a956e3a8-1a38-4fa9-bccd-f45b299c65f3 61 fields · synced Oct 6, 2026
- EUDAMED 41c6080c-7dff-4650-a539-077d477fac9e 61 fields · synced Jul 19, 2026