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Assy, Thoracic, Swivel Sternal Pad, Boston, Med
EUDAMEDClass I (EU MDR)
Ref 25TA-MModel Hypers
Identity
- Trade Name
- Assy, Thoracic, Swivel Sternal Pad, Boston, Med EUDAMED
- Device Name
- Hyperextension TLSO w/Dot Fastener EUDAMED
- Model / Reference
- Hypers EUDAMED25TA-M EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00194545145590 EUDAMED
- Basic UDI-DI
- 194545HYPERSES EUDAMED
- EMDN Code
- Y060308 LUMBOSACRAL SPINE ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Ireland 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
Assy, Thoracic, Swivel Sternal Pad, Boston, Med by Becker Orthopedic Appliance Company — 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 | 194545HYPERSES | Class I | Active |
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Manufacturer
- Manufacturer
- Becker Orthopedic Appliance Company
- EUDAMED SRN
- US-MF-000004002
- Authorised Representative
- Acorn Regulatory Consultancy Services Ltd IE-AR-000000592
Sources (1)
- EUDAMED bf446166-82af-4862-979b-c3ab6989fcaa 61 fields · synced Jun 18, 2026