Skip to content

Aesculap ET102R

by Aesculap AG

Ref ET102R

Aesculap ET102R is a Class I device made by Aesculap AG, registered in EUDAMED on 19 Jan 2026 (Basic UDI-DI 403923900000140524) and listed in FDA GUDID since 8 May 2020 (UDI-DI 04038653155002), 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 Number403923900000140524 Basic UDI-DI 04038653155002UDI-DIDate19 Jan 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04038653155002 UDI-DI Date8 May 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 403923900000140524 registered 19 Jan 2026 Active
  • FDA GUDID UDI-DI 04038653155002 listed 8 May 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04038653155002
  2. Registered EUDAMED 403923900000140524

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  • Withdrawn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
Aesculap
Generic name
Amniotome, reusable
Device name
Amniotome
Model / Ref / Catalog
ET102R
Primary DI / UDI-DI
04038653155002
Basic UDI-DI
403923900000140524
Direct marketing DI
04038653155002
FDA product code
HGE
EMDN code
L050802 Amniotomes, reusable
GMDN term
Amniotome, reusable
Device class
Class I
Regulation number
884.4530
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Other devices from Aesculap AG

See all devices from Aesculap AG →

Properties

  • Sterilise before use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
Other properties (21, all answered No)