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Aesculap EM134R

by Aesculap, Inc.

Part of a family of 61 devices: see the family page

Ref EM134R

Aesculap EM134R is a Class I device made by Aesculap, Inc., registered in EUDAMED on 2 Sep 2025 (Basic UDI-DI 40392390000006602F) and listed in FDA GUDID since 21 Apr 2020 (UDI-DI 04038653154067), active as of 23 Oct 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number40392390000006602F Basic UDI-DI 04038653154067UDI-DIDate2 Sep 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number04038653154067 UDI-DI Date21 Apr 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 40392390000006602F registered 2 Sep 2025 Active
  • FDA GUDID UDI-DI 04038653154067 listed 21 Apr 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04038653154067
  2. Registered EUDAMED 40392390000006602F

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  • Withdrawn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
Vaginal dilator
Device name
Uterus dilator
Model / Ref / Catalog
EM134R
Primary DI / UDI-DI
04038653154067
Basic UDI-DI
40392390000006602F
Direct marketing DI
04038653154067
FDA product code
HDQ
EMDN code
L0509020199 Gynecological use dilators, reusable - other
GMDN term
Vaginal dilator
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

Similar devices in this category

Other devices filed under GYNECOLOGICAL SURGERY INSTRUMENTS, REUSABLE.

Other devices from Aesculap, Inc.

See all devices from Aesculap, Inc. →

Properties

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