Arco
by ARCO Ltd. EUDAMED
Active
Ref 14HC109Model ARCO HC101 Exam Gloves - Blue Medical Grade Nitrile Disposable Gloves
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number5024273HC101EZ | Date23 Feb 2024 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Certificates
No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.
Specification
- Device Name
- ARCO HC101 Exam Gloves - Blue Medical Grade Nitrile Disposable Gloves
- Model / Reference
- ARCO HC101 Exam Gloves - Blue Medical Grade Nitrile Disposable Gloves, 14HC109
- Primary DI / UDI-DI
- 05024273108367
- Basic UDI-DI
- 5024273HC101EZ
- EMDN Code
- T01020204 Nitrile examination / treatment gloves
- Device Class
- Class I
- Market of Registration
- Austria
Manufacturer details
- EUDAMED SRN
- GB-MF-000033950
- Authorised representative
- European Healthcare & Device Solutions Ltd. IE-AR-000003999
Other devices from ARCO Ltd.
Properties
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