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OrbisTM Nitrile examination gloves, pink, size L
EUDAMEDClass I (EU MDR)
Ref 6009009
Identity
- Trade Name
- OrbisTM Nitrile examination gloves, pink, size L EUDAMED
- Device Name
- Nitrile examination gloves EUDAMED
- Model / Reference
- 6009009 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06438129380309 EUDAMED
- Basic UDI-DI
- 6438129B0001GU EUDAMED
- EMDN Code
- T01020204 NITRILE EXAMINATION / TREATMENT GLOVES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Finland 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
OrbisTM Nitrile examination gloves, pink, size L by OneMed Group Oy — 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 | 6438129B0001GU | Class I | Active |
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Manufacturer
- Manufacturer
- OneMed Group Oy
- EUDAMED SRN
- FI-MF-000000642
Sources (1)
- EUDAMED 3d12401f-4127-4e58-b7b6-82964ffd025c 61 fields · synced Sep 17, 2026