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PTS Personalized Tourniquet System for Blood Flow Restriction
EUDAMEDClass I (EU MDR)
Ref 9-2500-400BFR_M
Identity
- Device Name
- PTS Personalized Tourniquet System for Blood Flow Restriction EUDAMED
- Model / Reference
- 9-2500-400BFR_M EUDAMED
Identifiers
- Primary DI / UDI-DI
- +M99592500400BFRM3 EUDAMED
- Basic UDI-DI
- ++M9959IBFRREUD7 EUDAMED
- EMDN Code
- V9003 TOURNIQUETS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
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
PTS Personalized Tourniquet System for Blood Flow Restriction by Delfi Medical Innovations Inc. — Class I — MDR — listed in EUDAMED
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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 | ++M9959IBFRREUD7 | Class I | Active |
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Manufacturer
- Manufacturer
- Delfi Medical Innovations Inc.
- EUDAMED SRN
- CA-MF-000004434
- Authorised Representative
- International Associates Auditing & Certification Limited IE-AR-000002248
Sources (1)
- EUDAMED 2e042a97-6dbd-4a04-830d-66bb57d14e17 61 fields · synced Jun 18, 2026