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Neck Electronic Muscle Stimulator
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref Z12062801
Identity
- Trade Name
- Neck Electronic Muscle Stimulator EUDAMEDTranscutaneous Electrical Nerve Stimulators FDA UDI
- Generic Name
- Analgesic transcutaneous electrical nerve stimulation system FDA UDI
- Device Name
- Transcutaneous Electrical Nerve Stimulators EUDAMED
- Model / Reference
- Z12062801 EUDAMEDKTR-2232 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06924607702324 EUDAMEDFDA UDI
- Basic UDI-DI
- 69246077022497B EUDAMED
- 510(k) Number
- K191982 FDA UDI
- FDA Product Code
- NUH FDA UDINGX FDA UDI
- EMDN Code
- Z12062801 MUSCLE REINFORCEMENT STIMULATORS FOR INNERVATED MUSCLES EUDAMED
- GMDN Term
- Analgesic transcutaneous electrical nerve stimulation system FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 882.5890 FDA UDI890.5850 FDA UDI
- Market of Registration
- Türkiye EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Neck Electronic Muscle Stimulator by Shenzhen Kentro Medical Electronics Co., Ltd — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 69246077022497B | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Shenzhen Kentro Medical Electronics CO., LTD.
- EUDAMED SRN
- CN-MF-000011247
- Authorised Representative
- Share info GmbH DE-AR-000005132
Sources (2)
- EUDAMED 5a4d63cc-a1c8-4242-804c-19a5a9496670 61 fields · synced Jul 9, 2026
- FDA UDI 57394c45-9c6d-4306-ab69-5229fa81a648 33 fields · synced May 30, 2026