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Dental Sectional Contoured Matrices Kits

by Huanghua Promisee Dental Co.Ltd. 22 variants

Ref SC1807BModel SC01,SC1001,SC1101,SC0103,SC0104, SC1002,SC1102,SC15,SC1502,SC1503, SC1801,SC1802,SC1803,SC1804

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

CE MDR

Valid until

Not listed

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 2 Nov 2026. What this means

Regulatory status

as of registry sync 2 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number06954454014684 UDI-DI Date22 Oct 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number69544540DSCM001PC Basic UDI-DI 06954454014684UDI-DIDate7 Mar 2025RegisteredStatusActive

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.

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  • Withdrawn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
Dental Sectional Contoured Matrices Kits EUDAMED
Cotisen GUDID
Generic Name
Dental matrix band kit
Model / Reference
SC01, SC1001, SC1101, SC0103, SC0104, SC1002, SC1102, SC15, SC1502, SC1503, SC1801, SC1802, SC1803, SC1804, SC1807B
Primary DI / UDI-DI
06954454014684
Basic UDI-DI
69544540DSCM001PC
FDA Product Code
EKF
EMDN Code
Q01010199 Dental restoration devices - other
GMDN Term
Dental matrix band kit
Device Class
Class I
Regulation Number
872.4565
EU market of registration
Austria
GUDID distribution status
In Commercial Distribution

Manufacturer details

EUDAMED SRN
CN-MF-000014766
Authorised representative
MedNet EC-REP GmbH DE-AR-000000002

Related devices

Category: Dental appliance fabrication material, ceramic

Other devices from Huanghua Promisee Dental Co.Ltd.

See all devices from Huanghua Promisee Dental Co.Ltd. →

Properties

  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date

Other properties (21)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Manufacturing Date: No