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Plasmacup Sc NG400

by Aesculap AG

Part of a family of 6 devices: see the family page

Ref NG400

Plasmacup Sc NG400 is a Class I device made by Aesculap AG, registered in EUDAMED on 11 Aug 2026 (Basic UDI-DI 40392390000003862J) and listed in FDA GUDID since 20 May 2020 (UDI-DI 04038653116256), 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 Number40392390000003862J Basic UDI-DI 04038653116256UDI-DIDate11 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04038653116256 UDI-DI Date20 May 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 40392390000003862J registered 11 Aug 2026 Active
  • FDA GUDID UDI-DI 04038653116256 listed 20 May 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04038653116256
  2. Registered EUDAMED 40392390000003862J

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  • Withdrawn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
Plasmacup Sc
Generic name
Orthopaedic prosthesis implantation positioning instrument, reusable
Device name
PLASMACUP x-ray template
Model / Ref / Catalog
NG400
Primary DI / UDI-DI
04038653116256
Basic UDI-DI
40392390000003862J
FDA product code
HWT
EMDN code
L0999 Orthopaedic and traumatological surgery instruments, reusable - other
GMDN term
Orthopaedic prosthesis implantation positioning instrument, reusable
Device class
Class I
Regulation number
888.4800
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Related devices

Category: Orthopaedic prosthesis implantation positioning instrument, reusable

Similar devices in this category

Other devices filed under ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER.

Other devices from Aesculap AG

See all devices from Aesculap AG →

Properties

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