Identity
- Device Name
- 115-109-3536 EUDAMED
- Model / Reference
- HWS Implantate EUDAMED115-109-3536 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04250869662345 EUDAMED
- Basic UDI-DI
- B-04250869662345 EUDAMED
- EMDN Code
- P09070301 CERVICAL FIXATION SYSTEMS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
Yes
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
Category: Cervical spine immobilization system, single-use
115-109-3536 by Biedermann Motech GmbH & Co. KG — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-04250869662345 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Biedermann Motech GmbH & Co. KG
- EUDAMED SRN
- DE-MF-000005455
Sources (1)
- EUDAMED d3891904-4d28-4f3f-9197-dccd0b9c9e79 61 fields · synced Jul 9, 2026