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Pick-up Impression Coping PITRH70S

by Izenimplant Co., Ltd.

Ref PITRH70S

Pick-up Impression Coping PITRH70S is a Class I device made by Izenimplant Co., Ltd., registered in EUDAMED on 21 Sep 2026 (Basic UDI-DI B-08800070216682) and listed in FDA GUDID since 16 May 2022 (UDI-DI 08800070216682), 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-08800070216682 Basic UDI-DI 08800070216682UDI-DIDate21 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08800070216682 UDI-DI Date16 May 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-08800070216682 registered 21 Sep 2026 Active
  • FDA GUDID UDI-DI 08800070216682 listed 16 May 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 08800070216682
  2. Registered EUDAMED B-08800070216682

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  • Withdrawn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
Pick-up Impression Coping (Hex) EUDAMED
Pick-up Impression Coping GUDID
Generic name
Dental prosthesis/implant abutment screw analog, single-use
Model / reference
PITRH70S
Primary DI / UDI-DI
08800070216682
Basic UDI-DI
B-08800070216682
FDA product code
NDP
EMDN code
Q010503 Impression material trays, single-use
GMDN term
Dental prosthesis/implant abutment screw analog, single-use
Device class
Class I
Regulation number
872.3980
EU registration type
Legacy device (under a directive)
EU market of registration
Greece
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Dental prosthesis/implant abutment screw analog, single-use

Similar devices in this category

Other devices filed under IMPRESSION MATERIAL TRAYS, SINGLE-USE.

Other devices from Izenimplant Co., Ltd

See all devices from Izenimplant Co., Ltd →

Properties

  • Sterilise before use
  • Single use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (19, all answered No)