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Transcutaneous Electrical Nerve Stimulator
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref Z12062885Ref Z12062801
Identity
- Trade Name
- Transcutaneous Electrical Nerve Stimulator EUDAMEDFDA UDITranscutaneous Electrical Nerve Stimulators FDA UDI
- Generic Name
- Analgesic transcutaneous electrical nerve stimulation system FDA UDI
- Device Name
- Transcutaneous Electrical Nerve Stimulators EUDAMED
- Model / Reference
- Z12062885 EUDAMEDZ12062801 EUDAMEDKTR-2493 FDA UDIKTR-2650 FDA UDIKTR-2640 FDA UDIKTR-405 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06924607703246 EUDAMED06924607703222 EUDAMED06924607703239 EUDAMED06924607702423 EUDAMEDFDA UDI06924607703420 EUDAMED06924607702560 EUDAMEDFDA UDI06924607702454 EUDAMEDFDA UDI06924607702652 EUDAMEDFDA UDI06924607703598 EUDAMED06924607703499 EUDAMED06924607703345 EUDAMED06924607703512 EUDAMED06924607703581 EUDAMED06924607703413 EUDAMED06924607703291 EUDAMED06924607703536 EUDAMED06924607703543 EUDAMED
- Basic UDI-DI
- 69246077022497B EUDAMED
- FDA Product Code
- NUH FDA UDINGX FDA UDIIPF FDA UDINYN FDA UDIGZJ FDA UDI
- EMDN Code
- Z12062885 NEUROMUSCULAR STIMULATION EQUIPMENT - CONSUMABLES EUDAMEDZ12062801 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 EUDAMEDAustria EUDAMEDFrance EUDAMEDFinland EUDAMEDPoland EUDAMEDGermany EUDAMEDIreland 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
Transcutaneous Electrical Nerve Stimulator by Shenzhen Kentro Medical Electronics Co., Ltd — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA…
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
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 | K183288 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K200237 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 69246077022497B | Class IIa | Active |
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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 (22)
- EUDAMED 334ac36c-996a-461a-be10-b2065109b4b4 61 fields · synced Sep 18, 2026
- EUDAMED b43e8f71-80e8-40b9-8dc5-a8453bb09e74 61 fields · synced May 16, 2026
- EUDAMED 51deb6f8-1b3b-44d3-baaa-ce7325f5a4cc 61 fields · synced May 17, 2026
- EUDAMED 4b1b63ad-8bb1-4d5e-bb7a-e38b4ce7da4d 61 fields · synced May 17, 2026
- EUDAMED c4a28c54-3fa0-43cb-884a-0880d4b09512 61 fields · synced May 18, 2026
- FDA UDI d7b78caa-f0c3-4f65-83a5-db2f7bdb45ec 33 fields · synced May 30, 2026
- FDA UDI 760189c4-5a00-4deb-aa7c-2bf4378f75ec 33 fields · synced May 30, 2026
- FDA UDI f1727c79-bd4c-4deb-86eb-d4e5a6167bf1 33 fields · synced May 30, 2026
- FDA UDI c21aba61-cba5-49ad-9280-76354e004e0d 33 fields · synced May 30, 2026
- EUDAMED 4c4483f6-76c9-4ded-9a9e-dbc8df148223 61 fields · synced Jun 20, 2026
- EUDAMED eb04c474-ef7e-48d2-8730-0fa591942728 61 fields · synced Jul 9, 2026
- EUDAMED aca8bdc2-5fec-4a4a-a8d6-585726094e59 61 fields · synced Jul 9, 2026
- EUDAMED 5046849a-37bc-4597-af8a-a91c1998b2ba 61 fields · synced Jul 9, 2026
- EUDAMED e58f486f-4bdf-4a23-a4c0-f239cbf4a27d 61 fields · synced Jul 9, 2026
- EUDAMED bc7ca1fd-966f-49b4-b4a7-6688436e86b0 61 fields · synced Jul 10, 2026
- EUDAMED cd5fa380-3b14-457b-bad1-2711b982b5bc 61 fields · synced Jul 10, 2026
- EUDAMED 149746a8-2390-42d0-8d0f-605b9cdd20e6 61 fields · synced Jul 17, 2026
- EUDAMED cf65167a-3314-41ef-9b1f-2eed06990d47 61 fields · synced Jul 20, 2026
- EUDAMED a4e25b60-0e64-405a-8c85-1557bb116928 61 fields · synced Jul 23, 2026
- EUDAMED ed17db9f-df58-4331-a270-988274394dac 61 fields · synced Jul 23, 2026
- EUDAMED 51db495d-478a-4240-afe5-f08ff9ed4af4 61 fields · synced Jul 24, 2026
- FDA 510(k) K183288 1 fields · synced May 18, 2026