Thd Opti-Fiber (Revo/Bt)

Part of a family of 10 devices: see the family page

Ref 880012Model THD Opti-Fiber

Thd Opti-Fiber (Revo/Bt) (880012) is a device classified as Class I in the EU and Class II in the US made by Thd S.P.A., registered in EUDAMED on 3 Jul 2023 (Basic UDI-DI 803373771FOC000176), cleared under FDA 510(k) K090009 on 28 Jan 2009 and listed in FDA GUDID since 1 Sep 2022 (UDI-DI 08033737710777), active as of 23 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K090009

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDR EUDAMED	Number803373771FOC000176 Basic UDI-DI 08033737710777UDI-DI	Date3 Jul 2023Registered	StatusActive
United States	GUDID listing GUDID	Number08033737710777 UDI-DI	Date1 Sep 2022Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special	NumberK090009	Date28 Jan 2009Decided	StatusActive

Official records

EUDAMED public site Basic UDI-DI 803373771FOC000176 — open Devices and search for it
AccessGUDID record UDI-DI 08033737710777
FDA 510(k) database 510(k) number K090009

Across registries

3 registries list this device

EUDAMED Basic UDI-DI 803373771FOC000176 registered 3 Jul 2023 Active
FDA 510(k) K090009 decided 28 Jan 2009 Active
FDA GUDID UDI-DI 08033737710777 listed 1 Sep 2022 Listed

Timeline

3 dated events

28 Jan 2009 Cleared FDA 510(k) K090009
1 Sep 2022 Listed FDA GUDID 08033737710777
3 Jul 2023 Registered EUDAMED 803373771FOC000176

Coverage

2 jurisdictions

Active
Expiring
Withdrawn
Listed
Not covered

European Union CE/MDR Active
United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name: Thd Opti-Fiber (Revo/Bt) EUDAMED
Thd Slide One GUDID
Generic name: Fibreoptic light cable, reusable
Device name: THD Opti-Fiber
Model / Ref / Catalog: THD Opti-Fiber, 880012, THD OPTI-FIBER (REVO/BT)

Primary DI / UDI-DI: 08033737710777
Basic UDI-DI: 803373771FOC000176
Direct marketing DI: 08033737710777
510(k) Number: K090009
FDA product code: JAF
EMDN code: Z12019080 Various instruments for general and multidisciplinary surgery - hardware accessories
GMDN term: Fibreoptic light cable, reusable

Device class: Class I EUDAMED
Class II GUDID
Regulation number: 892.1540
EU registration type: Standard device
EU market of registration: Italy
GUDID distribution status: In Commercial Distribution

Sterilisation method: Moist Heat or Steam Sterilization

Truth per registry

2 sources · 2 fields differ

Field	EUDAMED	GUDID
Model / reference	EUDAMED THD Opti-Fiber 880012	GUDID THD OPTI-FIBER (REVO/BT)
Device class	EUDAMED Class I	GUDID Class II

Device class is stated on each registry's own scale: Class I in the EU (EUDAMED), Class II 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

Similar devices in this category

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Properties

Sterilise before use
Prescription use
Lot / batch number
Manufacturing date

Other properties (21, all answered No)