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FASPLINT HALFBACK with Carry Case and Compact Pump
EUDAMEDClass I (EU MDR)
Ref FSH 3000Model EV 3000
Identity
- Trade Name
- FASPLINT HALFBACK with Carry Case and Compact Pump EUDAMED
- Device Name
- EVAC-U-SPLINT Extremity Splint Set (Small, Medium and Large Splints, Compact Pump, Carry Case) EUDAMED
- Model / Reference
- EV 3000 EUDAMEDFSH 3000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00850012936640 EUDAMED
- Basic UDI-DI
- 0850012936VKITX6 EUDAMED
- EMDN Code
- V0804 PATIENT IMMOBILISERS (in diagnostic or therapeutic procedures) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands 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
FASPLINT HALFBACK with Carry Case and Compact Pump by Tri-Tech Forensics Inc. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 0850012936VKITX6 | Class I | Active |
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Manufacturer
- Manufacturer
- Tri-Tech Forensics Inc.
- EUDAMED SRN
- US-MF-000024012
- Authorised Representative
- MedEnvoy Global BV NL-AR-000024028
Sources (1)
- EUDAMED 661c50ec-b4d2-44fb-8bab-596637b81279 61 fields · synced Aug 3, 2026