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cold therapy system/set/unit

by Shanghai Youwen Medical Technology Co., Ltd. 3 variants

Ref handModel universal, hand, foot, knee, shoulder, head, wrist, waist, thigh, calf, hip, neck, back, elbow, ankle,

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, self-declared

Class I: no certifier involved

Trust

Unverified

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

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number06975803350413 UDI-DI Date25 Sep 2025ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number697580335YW04RQ Basic UDI-DI 06975803350413UDI-DIDate21 May 2025RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

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  • Withdrawn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
cold therapy system/set/unit
Model / Reference
universal EUDAMED
hand EUDAMED
foot EUDAMED
knee EUDAMED
shoulder EUDAMED
head EUDAMED
wrist EUDAMED
waist EUDAMED
thigh EUDAMED
calf EUDAMED
hip EUDAMED
neck EUDAMED
back EUDAMED
elbow EUDAMED
ankle EUDAMED
disposable face 2.0 GUDID
Primary DI / UDI-DI
06975803350413
Basic UDI-DI
697580335YW04RQ
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 · 1 field differs

FieldEUDAMEDGUDID
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

  • Single Use
  • Premarket Exempt
  • Lot / Batch Number

Other properties (21)

  • 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
  • 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