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Needle Stimulator
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref CMNS6-1 PLUSModel CMNS6-1 PLUS, CMNS6-3
Identity
- Trade Name
- Needle Stimulator EUDAMED
- Device Name
- Needle Stimulator EUDAMED
- Model / Reference
- CMNS6-1 PLUS, CMNS6-3 EUDAMEDCMNS6-1 PLUS EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972011718196 EUDAMED
- Basic UDI-DI
- 697201171D1000001HF EUDAMED
- Direct Marketing DI
- 06972011718196 EUDAMED
- EMDN Code
- Z120623 ACUPUNCTURE STIMULATORS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Spain 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
Needle Stimulator by Wuxi Jiajian Medical Instrument Co., Ltd. — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K244030 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 697201171D1000001HF | Class IIa | Active |
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Manufacturer
- Manufacturer
- Wuxi Jiajian Medical Instrument Co., Ltd.
- EUDAMED SRN
- CN-MF-000012006
- Authorised Representative
- Caretechion GmbH DE-AR-000005946
Sources (2)
- EUDAMED f9f1e6b8-81cc-4928-b5da-d3cc9c2d6f1e 61 fields · synced Jun 18, 2026
- FDA 510(k) K244030 1 fields · synced May 18, 2026