Identity
- Trade Name
- ARCO EUDAMED
- Device Name
- Arco HC102 Exam Gloves - Blue Accelerator Free Medical Grade Nitrile Disposable Gloves EUDAMED
- Model / Reference
- 14HC210 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05024273108428 EUDAMED
- Basic UDI-DI
- 5024273HC102F3 EUDAMED
- EMDN Code
- T01020204 NITRILE EXAMINATION / TREATMENT GLOVES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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
Arco by ARCO Ltd. — 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 | 5024273HC102F3 | Class I | Active |
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Manufacturer
- Manufacturer
- ARCO Ltd.
- EUDAMED SRN
- GB-MF-000033950
- Authorised Representative
- European Healthcare & Device Solutions Ltd. IE-AR-000003999
Sources (1)
- EUDAMED c31f16b8-819e-4f0c-8bac-449b65238608 61 fields · synced May 23, 2026