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Aesculap PO634R

by Aesculap, Inc.

Part of a family of 285 devices: see the family page

Ref PO634R

Aesculap PO634R is a device classified as Class IIb in the EU and Class II in the US made by Aesculap, Inc., registered in EUDAMED on 23 Jul 2026 (Basic UDI-DI 403923900000053429) and listed in FDA GUDID since 10 Oct 2016 (UDI-DI 04046963174385), active as of 22 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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number403923900000053429 Basic UDI-DI 04046963174385UDI-DIDate23 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04046963174385 UDI-DI Date10 Oct 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 403923900000053429 registered 23 Jul 2026 Active
  • FDA GUDID UDI-DI 04046963174385 listed 10 Oct 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04046963174385
  2. Registered EUDAMED 403923900000053429

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  • Withdrawn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
Adtec Monopolar EUDAMED
Aesculap GUDID
Generic name
Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
Device name
AdTec tissue grasp. fcps IIb non-sterile
Model / Ref / Catalog
PO634R
Primary DI / UDI-DI
04046963174385
Basic UDI-DI
403923900000053429
FDA product code
GCJ
EMDN code
L180402 Endoscopic electrosurgery forceps, reusable
GMDN term
Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
876.1500
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II

Device class is stated on each registry's own scale: Class IIb in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Endoscopic electrosurgical handpiece/electrode, monopolar, reusable

Similar devices in this category

Other devices filed under ENDOSCOPIC ELECTROSURGERY FORCEPS, REUSABLE.

Other devices from Aesculap, Inc.

See all devices from Aesculap, Inc. →

Properties

  • Sterilise before use
  • Prescription use
  • Lot / batch number
Other properties (22, all answered No)