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FASPLINT HALFBACK Only
EUDAMEDClass I (EU MDR)
Ref FSH 1000Model FS 801-9-001-CVT
Identity
- Trade Name
- FASPLINT HALFBACK Only EUDAMED
- Device Name
- Semi-Disposable Vacuum Splint (small) EUDAMED
- Model / Reference
- FS 801-9-001-CVT EUDAMEDFSH 1000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00850012936619 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 HALFBACK 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 2f5cb7ef-28f6-4934-85dd-cb8042f3876c 61 fields · synced Jul 10, 2026