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FASPLINT FULLBODY Only
EUDAMEDClass I (EU MDR)
Ref FSF 1000Model FS 801-9-001-CVT
Identity
- Trade Name
- FASPLINT FULLBODY Only EUDAMED
- Device Name
- Semi-Disposable Vacuum Splint (small) EUDAMED
- Model / Reference
- FS 801-9-001-CVT EUDAMEDFSF 1000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00850012936565 EUDAMED
- Basic UDI-DI
- 0850012936FS8R 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 Only 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 | 0850012936FS8R | 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 d3a7c682-4e0b-4be8-a326-cc049755efb5 61 fields · synced Aug 2, 2026