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Aesculap MB816R

by Aesculap, Inc.

Part of a family of 70 devices: see the family page

Ref MB816R

Aesculap MB816R is a Class I device made by Aesculap, Inc., registered in EUDAMED on 8 Oct 2025 (Basic UDI-DI 40392390000003932F) and listed in FDA GUDID since 30 Apr 2019 (UDI-DI 04046963450649), 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 Number40392390000003932F Basic UDI-DI 04046963450649UDI-DIDate8 Oct 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number04046963450649 UDI-DI Date30 Apr 2019ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 40392390000003932F registered 8 Oct 2025 Active
  • FDA GUDID UDI-DI 04046963450649 listed 30 Apr 2019 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04046963450649
  2. Registered EUDAMED 40392390000003932F

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  • Withdrawn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
Bone file/rasp, manual, reusable
Device name
Raspatorien
Model / Ref / Catalog
MB816R
Primary DI / UDI-DI
04046963450649
Basic UDI-DI
40392390000003932F
Direct marketing DI
04046963450649
FDA product code
GEG
EMDN code
L091201 Orthopaedic surgery rasps, reusable
GMDN term
Bone file/rasp, manual, 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: Bone file/rasp, manual, reusable

Similar devices in this category

Other devices filed under ORTHOPAEDIC SURGERY RASPS, 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)