Identity
- Device Name
- Cranial Stabilization System EUDAMED
- Model / Reference
- A700 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975412571544 EUDAMED
- Basic UDI-DI
- 697541257SCA001FY EUDAMED
- EMDN Code
- L99 SURGICAL INSTRUMENTS, REUSABLE - OTHER EUDAMED
Classification
- Device Class
- Class I 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
Category: Surgical retraction system, reusable
Cranial Stabilization System by Changzhou Huida Medical Instrument Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Surgical retraction system, reusable.
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- Thompson — Thompson Surgical Instruments · Class I
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- Thompson — Thompson Surgical Instruments · Class I
- Thompson — Thompson Surgical Instruments · Class I
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 | 697541257SCA001FY | Class I | Active |
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Manufacturer
- Manufacturer
- Changzhou Huida Medical Instrument Co., Ltd.
- EUDAMED SRN
- CN-MF-000051536
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 12a03411-f983-4a5a-90c6-7b3d0a129235 61 fields · synced Jun 19, 2026