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Featherweight Size 12

by Trulife

Ref 615 12Model Breastcare

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

CE MDR

Valid until

No date given

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number00643293Breastcare6Z Basic UDI-DI 00643293004678UDI-DIDate23 Apr 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number00643293004678 UDI-DI Date31 Dec 2022ListedStatusListed GUDID: in commercial distribution

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  • Withdrawn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
Featherweight Size 12 EUDAMED
Featherweight GUDID
Generic name
External breast prosthesis
Device name
Breastcare
Model / reference
Breastcare, 615 12
Primary DI / UDI-DI
00643293004678
Basic UDI-DI
00643293Breastcare6Z
FDA product code
NOJ
EMDN code
V9099 Various devices not included in other classes - other
GMDN term
External breast prosthesis
Device class
Class I
Regulation number
878.3800
EU registration type
Standard device
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution

Manufacturer details

EUDAMED SRN
IE-MF-000003108

Related devices

Category: Device sterilization/disinfection container, reusable

Other devices from Trulife

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Properties

  • Single use
  • Premarket exempt
  • Lot / batch number
  • Serial number
  • Manufacturing date

Other properties (20)

  • Supplied sterile: No
  • Sterilise before use: No
  • Implantable: No
  • Reusable: No
  • Contains latex: No
  • Reprocessed single-use device: No
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction): No
  • Incorporates a substance derived from human blood or plasma: No
  • Contains human tissues or cells: No
  • Contains animal tissues or cells: No
  • Contains endocrine-disrupting substances: No
  • Administering medicine: No
  • Measuring function: No
  • Incorporates a medicinal substance: No
  • Prescription use: No
  • Over-the-counter: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Expiration date: No