Identity
- Trade Name
- ClearBand EUDAMED
- Device Name
- Radial Artery Band EUDAMED
- Model / Reference
- Clear Band EUDAMEDNT/RAB/01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08906194160259 EUDAMED
- Basic UDI-DI
- 890619416NTRABNT EUDAMED
- EMDN Code
- C010402020180 PTA BALLOON DILATATION CATHETERS - ACCESSORIES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany 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
ClearBand by Newtech Medical Devices Pvt. Ltd. — Class IIa — 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 | 890619416NTRABNT | Class IIa | Active |
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Manufacturer
- Manufacturer
- Newtech Medical Devices Pvt. Ltd.
- EUDAMED SRN
- IN-MF-000045809
- Authorised Representative
- Amstermed B.V. NL-AR-000001971
Sources (1)
- EUDAMED 013c1514-5287-4304-abf9-91e5182a71f6 61 fields · synced Jul 9, 2026