Identity
- Trade Name
- EVAC-U-SPLINT System EUDAMED
- Device Name
- EVAC-U-SPLINT Extremity Splint Set (Small, Medium and Large Splints, Compact Pump, Carry Case) EUDAMED
- Model / Reference
- EV 3000 EUDAMEDEVS 9075-6C EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00850012936435 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
EVAC-U-SPLINT System 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 b13c7160-3687-4b9d-81b0-179f95bdbc69 61 fields · synced Jul 11, 2026