Identity
- Trade Name
- Helix EUDAMED
- Device Name
- Tourniquets EUDAMED
- Model / Reference
- 010224E EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06943030650156 EUDAMED
- Basic UDI-DI
- 69430306003001MR EUDAMED
- EMDN Code
- V9003 TOURNIQUETS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain 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
Category: Limb tourniquet, manual, reusable
Helix by Medplus Inc. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Limb tourniquet, manual, reusable.
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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 | 69430306003001MR | Class I | Active |
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Manufacturer
- Manufacturer
- Medplus Inc.
- EUDAMED SRN
- CN-MF-000016416
- Authorised Representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Sources (1)
- EUDAMED 692092bf-aed7-4655-ba4a-3cb4b78356eb 61 fields · synced Jun 18, 2026