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Helix
EUDAMEDClass I (EU MDR)
Ref 010216ERef 010217ERef 010211E
by Medplus Inc.
Identity
- Trade Name
- Helix EUDAMED
- Device Name
- Tourniquets EUDAMED
- Model / Reference
- 010216E EUDAMED010217E EUDAMED010211E EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06943030650057 EUDAMED06943030650040 EUDAMED06943030650019 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
Similar devices
Also classified as Limb tourniquet, manual, reusable.
- 10 cm x 3, 5 mt. İdeal Bandaj — TEMAŞ TIBBİ MALZEMELER VE SARGI BEZİ SANAYİ VE TİCARET ANONİM ŞİRKETİ · Class I
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- 15 cm x 5 mt. Ten Rengi İdeal Bandaj — TEMAŞ TIBBİ MALZEMELER VE SARGI BEZİ SANAYİ VE TİCARET ANONİM ŞİRKETİ · Class I
- TOURNIQUET — ZHENGZHOU MEDCONS IMPORT&EXPORT TRADING CO.,LTD · Class I
- garrot militaire combat application toueniquet — Danyang Sunmed Healthcare Corporation · Class I
- Constricting band — EMSRUN GROUP · Class I
- 200 Single use tourniquets InControl brand — ASEP HEALTHCARE LTD · Class I
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 (3)
- EUDAMED 0a5c4c25-4daf-48bd-b430-e592931808a7 61 fields · synced Aug 2, 2026
- EUDAMED 16d463f6-4746-49ab-946b-d9481f2b9892 61 fields · synced May 17, 2026
- EUDAMED d6e68e09-375e-425f-a632-54ba58e49c33 61 fields · synced May 18, 2026