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Apgar-Timer 017.0015

by Medela AG

Ref 017.0015

Apgar-Timer 017.0015 is a Class I device made by Medela AG, registered in EUDAMED on 25 Jun 2026 (Basic UDI-DI 07612367pzpxwfXW) and listed in FDA GUDID since 7 Jun 2023 (UDI-DI 07612367017428), active as of 12 Nov 2026.

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 linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 12 Nov 2026.

Regulatory status

as of registry sync 12 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number07612367pzpxwfXW Basic UDI-DI 07612367017428UDI-DIDate25 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07612367017428 UDI-DI Date7 Jun 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 07612367pzpxwfXW registered 25 Jun 2026 Active
  • FDA GUDID UDI-DI 07612367017428 listed 7 Jun 2023 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 07612367017428
  2. Registered EUDAMED 07612367pzpxwfXW

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  • Withdrawn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
Apgar-Timer
Generic name
Apgar score timer
Device name
Apgar Timer
Model / reference
017.0015
Primary DI / UDI-DI
07612367017428
Basic UDI-DI
07612367pzpxwfXW
FDA product code
LHB
EMDN code
Z12080399 Various childbirth support and maternal assistance instruments - other
GMDN term
Apgar score timer
Device class
Class I
Regulation number
880.2930
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Related devices

Category: Apgar score timer

Similar devices

Also classified as Apgar score timer.

Similar devices in this category

Other devices filed under VARIOUS CHILDBIRTH SUPPORT AND MATERNAL ASSISTANCE INSTRUMENTS - OTHER.

Other devices from Medela AG

See all devices from Medela AG →

Properties

  • Prescription use
  • Premarket exempt
  • Serial number
  • Manufacturing date
Other properties (21, all answered No)