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HemaClear XL (double sleeve)
EUDAMEDClass I (EU MDR)
Ref PRH-090-BW-02ARef PRH-090-BG-02A
Identity
- Trade Name
- HemaClear XL (double sleeve) EUDAMED
- Device Name
- HemaClear EUDAMED
- Model / Reference
- PRH-090-BW-02A EUDAMEDPRH-090-BG-02A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07290012685460 EUDAMED
- Basic UDI-DI
- 729001268HEMACLEAR3N EUDAMED
- Direct Marketing DI
- 07290012685460 EUDAMED
- EMDN Code
- V9003 TOURNIQUETS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy 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
HemaClear XL (double sleeve) by Oneg Hakarmel Ltd — 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 | 729001268HEMACLEAR3N | Class I | Active |
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Manufacturer
- Manufacturer
- Oneg HaKarmel Ltd
- EUDAMED SRN
- IL-MF-000028966
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (2)
- EUDAMED f687aaf3-de68-4721-baf2-339c8ac288e5 61 fields · synced Jun 18, 2026
- EUDAMED ac8719c5-c2a8-43cd-a29a-54d6178189b2 61 fields · synced Jun 18, 2026