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Tessys® CRC213240

by Joimax GmbH

Part of a family of 17 devices: see the family page

Ref CRC213240

Tessys® CRC213240 is a device classified as Class IIa in the EU and Class I in the US made by Joimax GmbH, registered in EUDAMED on 21 May 2026 (Basic UDI-DI 42503371REAMREAFD) and listed in FDA GUDID since 30 Dec 2022 (UDI-DI 04250337100218), 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 Number42503371REAMREAFD Basic UDI-DI 04250337100218UDI-DIDate21 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04250337100218 UDI-DI Date30 Dec 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 42503371REAMREAFD registered 21 May 2026 Active
  • FDA GUDID UDI-DI 04250337100218 listed 30 Dec 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04250337100218
  2. Registered EUDAMED 42503371REAMREAFD

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  • Withdrawn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
TESSYS® Crown Reamer, blue, coarse EUDAMED
Tessys® GUDID
Generic name
Orthopaedic bur, single-use
Device name
CESSYS® Cervical Reamer
Model / Ref / Catalog
CRC213240
Primary DI / UDI-DI
04250337100218
Basic UDI-DI
42503371REAMREAFD
Direct marketing DI
04250337100218
FDA product code
HTO
EMDN code
V901699 Specialist surgical instruments and kits not included in other classes, single-use - other
GMDN term
Orthopaedic bur, single-use
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
888.4540
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class I

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

Related devices

Category: Orthopaedic bur, single-use

Similar devices in this category

Other devices filed under SPECIALIST SURGICAL INSTRUMENTS AND KITS NOT INCLUDED IN OTHER CLASSES, SINGLE-USE - OTHER.

Other devices from Joimax GmbH

See all devices from Joimax GmbH →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (18, all answered No)