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compressible garment/sleeve/cuff

by Shanghai Youwen Medical Technology Co., Ltd. 9 variants

Ref kneeModel arm, shoulder, waist, calf, knee, thigh, leg, foot, the entire body

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number06975803350253 UDI-DI Date25 Sep 2025ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number697580335YW02RL Basic UDI-DI 06975803350253UDI-DIDate21 May 2025RegisteredStatusActive

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

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  • Withdrawn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

Trade Name
Youwen
Generic Name
Physical therapy transcutaneous neuromuscular electrical stimulation system
Device Name
compressible garment/sleeve/cuff
Model / Reference
arm EUDAMED
shoulder EUDAMED
waist EUDAMED
calf EUDAMED
knee EUDAMED
thigh EUDAMED
leg EUDAMED
foot EUDAMED
the entire body EUDAMED
black blanket GUDID
Primary DI / UDI-DI
06975803350253
Basic UDI-DI
697580335YW02RL
FDA Product Code
ILO
EMDN Code
V9099 Various devices not included in other classes - other
GMDN Term
Physical therapy transcutaneous neuromuscular electrical stimulation system
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
890.5720
EU market of registration
Austria
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
arm, shoulder, waist, calf, knee, thigh, leg, foot, the entire body
knee
GUDID
black blanket
Device ClassEUDAMED
Class I
GUDID
Class II

Manufacturer details

EUDAMED SRN
CN-MF-000047209
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Related devices

Category: Device sterilization/disinfection container, reusable

Other devices from Shanghai Youwen Medical Technology Co., Ltd.

See all devices from Shanghai Youwen Medical Technology Co., Ltd. →

Properties

  • Premarket Exempt
  • Lot / Batch Number

Other properties (22)

  • Sterile: No
  • Single Use: 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
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No