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02 Taper、04 Taper、05 Taper、06 Taper、Accessory Type、Protaper Type、Wave One GOLD、Reciproc Type、Next Type (035 06) · Shanwei Perfect Medical Instruments Co., Ltd. · DI 06942200925469

by Shanwei Perfect Medical Instruments Co., Ltd.

Part of a family of 160 devices: see the family page

Ref 035 06Model 02 Taper、04 Taper、05 Taper、06 Taper、Accessory Type、Protaper Type、Wave One GOLD、Reciproc Type、Next Type

02 Taper、04 Taper、05 Taper、06 Taper、Accessory Type、Protaper Type、Wave One GOLD、Reciproc Type、Next Type (035 06) · Shanwei Perfect Medical Instruments Co., Ltd. · DI 06942200925469 is a Class I device made by Shanwei Perfect Medical Instruments Co., Ltd., registered in EUDAMED on 28 Aug 2025 (Basic UDI-DI 69422009APPXM), active as of 7 Nov 2026.

Active European Union

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Source EUDAMED, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69422009APPXM Basic UDI-DI 06942200925469UDI-DIDate28 Aug 2025RegisteredStatusActive

Official records

Certificates

0 certificates · EUDAMED

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

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Full name
/
Device name
Absorbent Paper Points
Model / reference
02 Taper、04 Taper、05 Taper、06 Taper、Accessory Type、Protaper Type、Wave One GOLD、Reciproc Type、Next Type, 035 06
Primary DI / UDI-DI
06942200925469
Basic UDI-DI
69422009APPXM
EMDN code
Q01010401 Paper and gutta-percha tips, matrices and wedges for dentistry
Device class
Class I
EU registration type
Standard device
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000033003
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Similar devices in this category

Other devices filed under PAPER AND GUTTA-PERCHA TIPS, MATRICES AND WEDGES FOR DENTISTRY.

Other devices from Shanwei Perfect Medical Instruments Co., Ltd.

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Properties

  • Sterilise before use
Other properties (13, all answered No)