Identity
- Device Name
- Needle Holder EUDAMED
- Model / Reference
- SD001, SD002 EUDAMEDN/A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973905960011 EUDAMED
- Basic UDI-DI
- 697390596NH001LN EUDAMED
- EMDN Code
- A018099 NEEDLES - OTHER ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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: Electromagnetic surgical navigation device tracking system
Needle Holder by Shandong Chengwu Medical Products Factory — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Electromagnetic surgical navigation device tracking system.
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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 | 697390596NH001LN | Class I | Active |
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Manufacturer
- Manufacturer
- Shandong Chengwu Medical Products Factory
- EUDAMED SRN
- CN-MF-000003370
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (2)
- EUDAMED 1b2757e7-ac6c-480e-a617-e45c9d55f19f 61 fields · synced Jun 18, 2026
- EUDAMED 1b2757e7-ac6c-480e-a617-e45c9d55f19f-1 61 fields · synced Jun 9, 2026