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THERA-vital

by medica Medizintechnik GmbH

Ref A000-525; A002-461

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number04041925006179 UDI-DI Date28 Aug 2025ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number4041925tigoFN Basic UDI-DI 04041925006179UDI-DIDate27 Aug 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  • Withdrawn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
THERA-vital EUDAMED
THERA-Trainer tigo GUDID
Generic Name
Continuous passive motion joint exerciser
Model / Reference
A000-525 EUDAMED
A002-461 EUDAMED
04.XX.XX GUDID
Primary DI / UDI-DI
04041925006179
Basic UDI-DI
4041925tigoFN
FDA Product Code
BXB
EMDN Code
Y0599 Learning and training devices - other
GMDN Term
Continuous passive motion joint exerciser
Device Class
Class IIa EUDAMED
Class I GUDID
Regulation Number
890.5380
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
A000-525; A002-461
GUDID
04.XX.XX
Device ClassEUDAMED
Class IIa
GUDID
Class I

Manufacturer details

EUDAMED SRN
DE-MF-000005058

Other devices from medica - Medizintechnik GmbH

See all devices from medica - Medizintechnik GmbH →

Properties

  • Premarket Exempt
  • Serial 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
  • Lot / Batch Number: No
  • Expiration Date: No
  • Manufacturing Date: No