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Aesculap PE184A

by Aesculap AG

Ref PE184A

Aesculap PE184A is a device classified as Class III in the EU and Class II in the US made by Aesculap AG, registered in EUDAMED on 6 Jul 2026 (Basic UDI-DI 40392390000014842S) with CE/MDR certificate 20003GB450260622 valid until 22 Jun 2031 and listed in FDA GUDID since 19 May 2016 (UDI-DI 04038653081295), active as of 12 Nov 2026.

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

22 Jun 2031

CE MDR certificate

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

1 certificate

Certifier DNV MEDCERT GmbH

Trust

Unverified

Source EUDAMED, GUDID, synced 12 Nov 2026.

Regulatory status

as of registry sync 12 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number40392390000014842S Basic UDI-DI 04038653081295UDI-DIDate6 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04038653081295 UDI-DI Date19 May 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 40392390000014842S registered 6 Jul 2026 Active· +1 more in the status table
  • FDA GUDID UDI-DI 04038653081295 listed 19 May 2016 Listed

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 20003GB450260622 Active Reissued

    Technical documentation EU MDR

    Certifier
    DNV MEDCERT GmbH 0482
    Issued
    22 Jun 2026
    Expires
    22 Jun 2031
    Valid from
    23 Jul 2026

Timeline

4 dated events

  1. Listed FDA GUDID 04038653081295
  2. Certificate issued EUDAMED 20003GB450260622
  3. Registered EUDAMED 40392390000014842S
  4. Certificate expires EUDAMED 20003GB450260622

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  • Withdrawn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
Minop® EUDAMED
Aesculap GUDID
Generic name
Rigid optical intracranial/spinal endoscope, reusable
Device name
MINOP Neuroendoscope
Model / Ref / Catalog
PE184A
Primary DI / UDI-DI
04038653081295
Basic UDI-DI
40392390000014842S
FDA product code
GWG
EMDN code
Z12020902 Neuroscopes
GMDN term
Rigid optical intracranial/spinal endoscope, reusable
Device class
Class III EUDAMED
Class II GUDID
Regulation number
882.1480
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 III
GUDID
Class II

Device class is stated on each registry's own scale: Class III 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: Rigid optical intracranial/spinal endoscope, reusable

Similar devices in this category

Other devices filed under NEUROSCOPES.

Other devices from Aesculap AG

See all devices from Aesculap AG →

Properties

  • Sterilise before use
  • Prescription use
  • Serial number
Other properties (22, all answered No)