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Aesculap BT622R

by Aesculap, Inc.

Ref BT622R

Aesculap BT622R is a Class I device made by Aesculap, Inc., registered in EUDAMED on 15 Sep 2025 (Basic UDI-DI 40392390000011992Q) and listed in FDA GUDID since 21 May 2020 (UDI-DI 04038653142040), 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 Number40392390000011992Q Basic UDI-DI 04038653142040UDI-DIDate15 Sep 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number04038653142040 UDI-DI Date21 May 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 40392390000011992Q registered 15 Sep 2025 Active
  • FDA GUDID UDI-DI 04038653142040 listed 21 May 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04038653142040
  2. Registered EUDAMED 40392390000011992Q

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  • Withdrawn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
Hand-held surgical retractor, reusable
Device name
Abdominal retractor Mikulicz Ir
Model / Ref / Catalog
BT622R
Primary DI / UDI-DI
04038653142040
Basic UDI-DI
40392390000011992Q
Direct marketing DI
04038653142040
FDA product code
GAD
EMDN code
L040901 Abdominal spreaders, reusable
GMDN term
Hand-held surgical retractor, reusable
Device class
Class I
Regulation number
878.4800
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Hand-held surgical retractor, reusable

Similar devices in this category

Other devices filed under ABDOMINAL SURGERY INSTRUMENTS, REUSABLE.

Other devices from Aesculap, Inc.

See all devices from Aesculap, Inc. →

Properties

  • Sterilise before use
  • Reusable
  • Prescription use
  • Premarket exempt
  • Lot / batch number
Other properties (20, all answered No)