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BL Surgical cassette(Complete ) 156020

by BIO CONCEPT Co., Ltd.

Ref 069476003001801FB

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number069476003001801FB Basic UDI-DI Date27 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number06947600309000 UDI-DI Date1 Sep 2016ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

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  • Withdrawn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
Kit EUDAMED
BL Surgical cassette(Complete ) GUDID
BV Wide Kit GUDID
BV Prosthetic Kit GUDID
Surgical Instruments Kit(Standard) GUDID
BV MINI Kit GUDID
BV Guided Kit,BV GUDID
BV Standard KlT GUDID
Bl Mini Kit GUDID
Tl Mini Kit GUDID
BC Prosthetic Kit GUDID
BLT Surgical Kit GUDID
Generic Name
Dental implant system
Dental/maxillofacial surgical procedure kit, non-medicated, reusable
Model / Reference
069476003001801FB EUDAMED
156020 GUDID
356800 GUDID
356300 GUDID
356400 GUDID
357600 GUDID
357300 GUDID
357860 GUDID
156200 GUDID
056500 GUDID
056400 GUDID
156070 GUDID
Primary DI / UDI-DI
06947600309000, 06947600316374, 06947600316329, 06947600316336, 06947600316589, 06947600316596, 06947600319948, 06947600304388, 06947600302094, 06947600302087, 06947600304333, 06947600305439, 06947600316381, 06947600316923, 06947600309017, 06947600304555, 06947600331186
Basic UDI-DI
069476003001801FB
510(k) Number
FDA Product Code
DZE, NHA, NYE
EMDN Code
L159099 Odontostomatology instruments, reusable - other
GMDN Term
Dental implant system
Dental/maxillofacial surgical procedure kit, non-medicated, reusable
Device Class
Class IIa EUDAMED
Class II GUDID
Class I GUDID
Regulation Number
872.3640, 872.3630, 872.3980
Medical Purpose
The devices are intended to be used for planning, placement, maintenance and explantation of the implants from BIOCONCEPT Dental Implant System.
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
069476003001801FB
GUDID
156020
356800
356300
356400
357600
357300
357860
156200
056500
056400
156070
Device ClassEUDAMED
Class IIa
GUDID
Class II
Class I

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Cleared under the same submission (K150388)

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Properties

  • Single Use YesGUDIDNoGUDID
  • Implantable YesGUDIDNoGUDID
  • Prescription Use NoGUDIDYesGUDID
  • Convenience Kit NoGUDIDYesGUDID
  • Premarket Exempt NoGUDIDYesGUDID
  • Lot / Batch Number NoGUDIDYesGUDID
  • Serial Number YesGUDIDNoGUDID
  • Manufacturing Date

Other properties (6)

  • Sterile: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Expiration Date: No