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Thd Biopsy (J)

by Thd S.P.A.

Ref 800317Model THD BIOPSY

Thd Biopsy (J) (800317) is a device classified as Class IIa in the EU and Class I in the US made by Thd S.P.A., registered in EUDAMED on 20 Mar 2026 (Basic UDI-DI 803373771BPO0016B) and listed in FDA GUDID since 7 Jan 2026 (UDI-DI 08051887049851), active as of 23 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number803373771BPO0016B Basic UDI-DI 08051887049851UDI-DIDate20 Mar 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08051887049851 UDI-DI Date7 Jan 2026ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 803373771BPO0016B registered 20 Mar 2026 Active
  • FDA GUDID UDI-DI 08051887049851 listed 7 Jan 2026 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 08051887049851
  2. Registered EUDAMED 803373771BPO0016B

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  • Withdrawn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
Thd Biopsy (J) EUDAMED
Thd Biopsy GUDID
Generic name
Rigid endoscopic biopsy forceps, single-use
Model / Ref / Catalog
THD BIOPSY, 800317, THD BIOPSY (J)
Primary DI / UDI-DI
08051887049851
Basic UDI-DI
803373771BPO0016B
FDA product code
FCL
EMDN code
G0308010101 Gastrointestinal endoscopy, cold biopsy forceps, single-use
GMDN term
Rigid endoscopic biopsy forceps, single-use
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
876.1075
EU registration type
Standard device
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution
Size
Length — 18 Centimeter

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
THD BIOPSY
800317
GUDID
THD BIOPSY (J)
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.

Manufacturer details

EUDAMED SRN
IT-MF-000029427

Related devices

Category: Flexible endoscopic biopsy forceps, single-use

Similar devices in this category

Other devices filed under GASTROINTESTINAL ENDOSCOPY, COLD BIOPSY FORCEPS, SINGLE-USE.

Other devices from Thd S.P.A.

See all devices from Thd S.P.A. →

Properties

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