Identity
- Trade Name
- Spinal Orthosis EUDAMED
- Device Name
- Spinal Orthosis EUDAMED
- Model / Reference
- TLSO-O-BZT-01 EUDAMED001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977938052224 EUDAMED
- Basic UDI-DI
- 697793805001QQ EUDAMED
- EMDN Code
- Y060399 SPINE ORTHOSES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Spinal Orthosis by PoseTec Biotechnology (HuNan) Co., Ltd. — 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 | 697793805001QQ | Class I | Active |
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Manufacturer
- Manufacturer
- PoseTec Biotechnology (HuNan) Co., Ltd.
- EUDAMED SRN
- CN-MF-000046126
- Authorised Representative
- BioDomi GmbH DE-AR-000016611
Sources (1)
- EUDAMED 04f61bf7-9f02-419d-8cdd-b1a99b7b8d05 61 fields · synced Jul 21, 2026