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Regain

by Shenzhen AsTec Technology Co., Ltd

Ref AS8011Model AS1080, AS8012,AS8018,AS8012C,AS8016,AS8012B,AS8011,AS8015,AS2015,AS8019, AS9020, AS2080,AS9026,AS9034,AS9020E AS9038（ViaMed),AS2016(IonMedx) AS9022 AS2503B AS9024AS9035

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number0697089032TENSA6 Basic UDI-DI 06970890320776UDI-DIDate22 May 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
TENS and Muscle stimulator
Model / Reference
AS1080, AS8012, AS8018, AS8012C, AS8016, AS8012B, AS8011, AS8015, AS2015, AS8019, AS9020, AS2080, AS9026, AS9034, AS9020E AS9038（ViaMed), AS2016(IonMedx) AS9022 AS2503B AS9024AS9035
Primary DI / UDI-DI
06970890320776
Basic UDI-DI
0697089032TENSA6
EMDN Code
N010299 Neurologic physiotheraphy devices - other
Device Class
Class IIa
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000031961
Authorised representative
MedNet EC-REP GmbH DE-AR-000000002

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Properties

Other properties (13)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No