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Piranha 8970011

by Richard Wolf GmbH

Ref 8970.011Model 10000201374

Piranha 8970011 (8970.011) is a device classified as Class IIa in the EU and Class II in the US made by Richard Wolf GmbH, registered in EUDAMED on 26 Oct 2026 (Basic UDI-DI B-04055207044988) and listed in FDA GUDID since 23 Sep 2016 (UDI-DI 04055207044988), active as of 7 Nov 2026.

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

CE MDD

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 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-04055207044988 Basic UDI-DI 04055207044988UDI-DIDate26 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04055207044988 UDI-DI Date23 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-04055207044988 registered 26 Oct 2026 Active
  • FDA GUDID UDI-DI 04055207044988 listed 23 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04055207044988
  2. Registered EUDAMED B-04055207044988

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
Piranha
Generic name
Tissue morcellation system
Device name
Rotation morcellators for motorized use
Model / Ref / Catalog
10000201374, 8970.011, 8970011
Description
ROTATIONS-MORCELLATOR Ø 4.8MM WL 350MM for MORCESCOPE, for morcellation following laser prostate enucleation, reusable
Primary DI / UDI-DI
04055207044988
Basic UDI-DI
B-04055207044988
FDA product code
FJL
EMDN code
U090299 Urogenital endoscopic resection instruments - other
GMDN term
Tissue morcellation system
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
876.1500
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization
Size
Length — 350 Millimeter
Outer Diameter — 4.8 Millimeter

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
10000201374
8970.011
GUDID
8970011
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa 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: Tissue morcellation system

Similar devices in this category

Other devices filed under UROGENITAL ENDOSCOPIC RESECTION INSTRUMENTS - OTHER.

Other devices from Richard Wolf GmbH

See all devices from Richard Wolf GmbH →

Properties

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