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FASPLINT FULLBODY with Carry Case and Compact Vacuum Pump
EUDAMEDClass I (EU MDR)
Ref FSF 3000CModel EV 3000
Identity
- Trade Name
- FASPLINT FULLBODY with Carry Case and Compact Vacuum Pump EUDAMED
- Device Name
- EVAC-U-SPLINT Extremity Splint Set (Small, Medium and Large Splints, Compact Pump, Carry Case) EUDAMED
- Model / Reference
- EV 3000 EUDAMEDFSF 3000C EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00850012936602 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 FULLBODY with Carry Case and Compact Vacuum 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 95463037-4a3a-456c-ad46-722b88910a25 61 fields · synced Jul 12, 2026