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TF4

by Shanwei Perfect Medical Instruments Co., Ltd. 5 variants

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

Ref Primary(025 07)Model 02 Taper、04 Taper、05 Taper、06 Taper、Accessory Type、Protaper Type、Wave One GOLD、Reciproc Type、Next Type

TF4 (Primary(025 07)) 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 Date28 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  • Withdrawn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

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, Primary(025 07)
Primary DI / UDI-DI
06942200925803, 06942200924998
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.

See all devices from Shanwei Perfect Medical Instruments Co., Ltd. →

Properties

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