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Sterilization Pouch

by Huanghua Promisee Dental Co.Ltd. 14 variants

Ref MJD0213Model MJD0201,MJD0202,MJD0203, MJD0204,MJD0205,MJD0206,MJD0207, MJD0208, MJD0209, MJD0210,MJD0301,MJD0302,MJD0303,MJD0304, MJD0305,MJD0306,MJD0307,MJD0308

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, self-declared

Class I: no certifier involved

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 Number06954454014011 UDI-DI Date22 Oct 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number69544540STPO0024S Basic UDI-DI 06954454014011UDI-DIDate19 Mar 2025RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

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  • Withdrawn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
Sterilization Pouch EUDAMED
Cotisen GUDID
Generic Name
Sterilization packaging, single-use
Model / Reference
MJD0201, MJD0202, MJD0203, MJD0204, MJD0205, MJD0206, MJD0207, MJD0208, MJD0209, MJD0210, MJD0301, MJD0302, MJD0303, MJD0304, MJD0305, MJD0306, MJD0307, MJD0308, MJD0213
Primary DI / UDI-DI
06954454014011
Basic UDI-DI
69544540STPO0024S
FDA Product Code
NRD
EMDN Code
Q010599 Dental instruments, single-use - other
GMDN Term
Sterilization packaging, single-use
Device Class
Class I
Regulation Number
872.6640
EU market of registration
Cyprus
GUDID distribution status
In Commercial Distribution

Manufacturer details

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

Other devices from Huanghua Promisee Dental Co.Ltd.

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

Properties

  • Single Use
  • Reprocessed
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date

Other properties (19)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: 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