Identity
- Trade Name
- HemaClear Model A EUDAMEDHemaClear FDA UDI
- Generic Name
- Tourniquet cuff, single-use FDA UDI
- Device Name
- HemaClear EUDAMEDAll in One Surgical Tourniquet for Limb Surgery FDA UDI
- Model / Reference
- PRH032MA01A EUDAMEDModel A (F&A) Sterile Single Unit FDA UDI
- Description
- All in One Surgical Tourniquet for Limb Surgery FDA UDI
Identifiers
- Catalog Number
- SAH-032-MA-01A FDA UDI
- Primary DI / UDI-DI
- 07290012685293 EUDAMEDFDA UDI
- Basic UDI-DI
- 729001268HEMACLEAR3N EUDAMED
- Direct Marketing DI
- 07290012685293 EUDAMED
- FDA Product Code
- GAX FDA UDI
- EMDN Code
- V9003 TOURNIQUETS EUDAMED
- GMDN Term
- Tourniquet cuff, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.5900 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
HemaClear Model A by Oneg Hakarmel Ltd — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 729001268HEMACLEAR3N | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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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 adad3fcf-7dcc-40a0-8eba-02b53b282e16 61 fields · synced Jun 20, 2026
- FDA UDI 0b90dffd-4be2-48ff-a45a-71309e79adee 34 fields · synced May 30, 2026