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Disposable Bite Block AC01-107.M

by Micro-Tech (Nanjing) Co., Ltd.

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

Ref AC01-107.M

Disposable Bite Block AC01-107.M is a Class I device made by Micro-Tech (Nanjing) Co., Ltd., registered in EUDAMED on 2 Jul 2026 (Basic UDI-DI 6902284BB341436P) and listed in FDA GUDID since 31 Dec 2021 (UDI-DI 06902284543058), active as of 24 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 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number6902284BB341436P Basic UDI-DI 06902284543058UDI-DIDate2 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number06902284543058 UDI-DI Date31 Dec 2021ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 6902284BB341436P registered 2 Jul 2026 Active
  • FDA GUDID UDI-DI 06902284543058 listed 31 Dec 2021 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 06902284543058
  2. Registered EUDAMED 6902284BB341436P

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  • Withdrawn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
Disposable Bite Block
Generic name
Endoscopic bite block, basic, single-use
Model / reference
AC01-107.M
Primary DI / UDI-DI
06902284543058 EUDAMED
06932503560030 GUDID
Basic UDI-DI
6902284BB341436P
FDA product code
MNK
EMDN code
G030804 Gastrointestinal endoscopy and echoendoscopy, bite blocks
GMDN term
Endoscopic bite block, basic, single-use
Device class
Class I
Regulation number
876.1500
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
06902284543058
GUDID
06932503560030
Supplied sterileEUDAMED
No
GUDID
Yes

The registries describe this device under different primary UDI-DIs (EUDAMED lists 06902284543058; FDA GUDID lists 06932503560030), so their flags are not compared.

Related devices

Category: Endoscopic bite block, basic, single-use

Similar devices in this category

Other devices filed under GASTROINTESTINAL ENDOSCOPY AND ECHOENDOSCOPY, BITE BLOCKS.

Other devices from Micro-Tech (Nanjing) Co., Ltd.

See all devices from Micro-Tech (Nanjing) Co., Ltd. →

Properties

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