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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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  • MD Atlas
  • Andon Health Co., Ltd.

Data from EUDAMED, last updated Jun 11, 2026

Transcutaneous Electrical Nerve Stimulators (TENS Device)

69302518TENS04NY

19 references

Class IIa
Applicable legislation
MDR [Regulation (EU) 2017/745 on medical devices]
Risk category
Class IIa
Manufacturer
Andon Health Co., Ltd.

Device family identification

Device name
Transcutaneous Electrical Nerve Stimulators (TENS Device)
Basic UDI-DI
69302518TENS04NY
Issuing agency
GS1
Version date
Feb 11, 2026

Classification

Applicable legislation
MDR [Regulation (EU) 2017/745 on medical devices]
Risk category
Class IIa
Status
On the market

Manufacturer & authorised representative

Manufacturer

Name
Andon Health Co., Ltd.
SRN
CN-MF-000001799
Country
China
Email
fda@jiuan.com

Authorised representative

Name
iHealthLabs Europe
SRN
FR-AR-000000340
Country
France

Device characteristics

Active device

EMDN code(s)

European Medical Device Nomenclature — the EU product classifications carried across this device family's references.

  • Z12062801Muscle reinforcement stimulators for innervated muscles

References by status

References

19 references

Export results

Applied filters

  • basicUdiUlid·01KH5T5XZKG35NFPKJMN6Y53F8

Format

Summary

31 columns included
  • Trade name
  • Basic UDI-DI
  • UDI-DI code
  • Risk category
  • Applicable legislation
  • Status
  • Organization name
  • SRN
  • Reference / catalog number
  • Additional product description
  • Intended medical purpose
  • Market country
  • Issuing entity
  • Market info update date
  • Sterile
  • Single use
  • Contains latex
  • Reprocessed single-use
  • Direct marking
  • CMR substance
  • Endocrine disruptor
  • Annex XVI applicable
  • Sterilization
  • OEM applicable
  • EMDN codes
  • Last updated
  • Basic UDI-DI device name
  • Basic UDI-DI device model
  • Basic UDI-DI implantable
  • Basic UDI-DI reagent
  • DM Atlas link
Trade nameReference / catalog numberUDI-DI codeQuantityStatus
EM 38/1(AD-2128)AD-2128069302518031641On the market
SEM 26 (866.92)(AD-2128)AD-2128069302518027781On the market
SEM 26 (866.93)(AD-2128)AD-2128069302518027851On the market
SEM 26 (866.94)(AD-2128)AD-2128069302518027921On the market
SEM 26 (866.95)(AD-2128)AD-2128069302518028081On the market
SEM 26-29 Assortment (866.88)(AD-2128)AD-2128069302518029381On the market
SEM 27 (867.00)(AD-2128)AD-2128069302518028151On the market
SEM 27 (867.01)(AD-2128)AD-2128069302518028221On the market
SEM 27 (867.02)(AD-2128)AD-2128069302518028461On the market
SEM 27 (867.03)(AD-2128)AD-2128069302518028391On the market
SEM 28 (867.04)(AD-2128)AD-2128069302518028531On the market
SEM 28 (867.05)(AD-2128)AD-2128069302518028601On the market
SEM 28 (867.06)(AD-2128)AD-2128069302518028841On the market
SEM 28 (867.07)(AD-2128)AD-2128069302518028771On the market
SEM 29 (866.96)(AD-2128)AD-2128069302518028911On the market
SEM 29 (866.97)(AD-2128)AD-2128069302518029071On the market
SEM 29 (866.98)(AD-2128)AD-2128069302518029141On the market
SEM 29 (866.99)(AD-2128)AD-2128069302518029211On the market
AD-2128AD-2128069302518029451On the market