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Electronic Muscle Stimulator

by Shenzhen OSTO Medical Technology Company Limited 26 variants

Ref AST-300W

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number695094080001GT Basic UDI-DI 06950940802087UDI-DIDate26 Dec 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number06950940802087 UDI-DI Date30 Aug 2024ListedStatusListed GUDID: in commercial distribution

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.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Generic Name
Acupuncture electrical stimulation system
Device Name
Electronic Muscle Stimulator
Model / Reference
AST-300W
Primary DI / UDI-DI
06950940802087
Basic UDI-DI
695094080001GT
510(k) Number
FDA Product Code
NGX, NUH
EMDN Code
Z12062801 Muscle reinforcement stimulators for innervated muscles
GMDN Term
Acupuncture electrical stimulation system
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
890.5850, 882.5890
EU market of registration
Denmark
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
CN-MF-000022960
Authorised representative
phoenix Medtech GmbH DE-AR-000007996

Other devices from Shenzhen OSTO Medical Technology Company Limited

See all devices from Shenzhen OSTO Medical Technology Company Limited →

Properties

  • Reusable
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (20)

  • Sterile: No
  • Single Use: No
  • Implantable: 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
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No