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PragmaTool RJ8112033

by Hangzhou Rejoin Mastin Medical Device Co., Ltd.

Ref RJ8112033

PragmaTool RJ8112033 is a device classified as Class IIa in the EU and Class I in the US made by Hangzhou Rejoin Mastin Medical Device Co., Ltd., registered in EUDAMED on 15 Jul 2026 (Basic UDI-DI B-06973877664009) and listed in FDA GUDID since 22 May 2023 (UDI-DI 06973877664009), active as of 24 Oct 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 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-06973877664009 Basic UDI-DI 06973877664009UDI-DIDate15 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number06973877664009 UDI-DI Date22 May 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-06973877664009 registered 15 Jul 2026 Active
  • FDA GUDID UDI-DI 06973877664009 listed 22 May 2023 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 06973877664009
  2. Registered EUDAMED B-06973877664009

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  • Withdrawn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
PragmaTool
Generic name
Surgical drill guide, single-use
Device name
Drills
Model / reference
RJ8112033
Primary DI / UDI-DI
06973877664009
Basic UDI-DI
B-06973877664009
FDA product code
HTW
EMDN code
P091303 Orthopaedic implant drill bits, single-use
GMDN term
Surgical drill guide, single-use
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
888.4540
EU registration type
Legacy device (under a directive)
EU market of registration
France
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: Surgical drill guide, single-use

Similar devices in this category

Other devices filed under ORTHOPAEDIC IMPLANT DRILL BITS, SINGLE-USE.

Other devices from Hangzhou Rejoin Mastin Medical Device Co., Ltd.

See all devices from Hangzhou Rejoin Mastin Medical Device Co., Ltd. →

Properties

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