Identity
- Trade Name
- 3D Spine Detector EUDAMED
- Device Name
- 3D Spine Detector EUDAMED
- Model / Reference
- MW01/MW02 EUDAMED001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977948470018 EUDAMED
- Basic UDI-DI
- 697794847001T3 EUDAMED
- EMDN Code
- V030299 DIMENSIONAL CLINICAL PARAMETERS MEASURING DEVICES - 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
3D Spine Detector by Hunan MindReal Technology 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 | 697794847001T3 | Class I | Active |
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Manufacturer
- Manufacturer
- Hunan MindReal Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000046127
- Authorised Representative
- BioDomi GmbH DE-AR-000016611
Sources (1)
- EUDAMED 73d2e17d-d6a0-47a2-8b9b-4177b767b0b2 61 fields · synced Jul 10, 2026