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Screw

by Tianjin Coral Biotechnology Co., Ltd 65 variants

Part of a family of 65 devices: see the family page

Ref SW01SY

Screw (SW01SY) is a Class I device made by Tianjin Coral Biotechnology Co., Ltd, registered in EUDAMED on 14 Apr 2026 (Basic UDI-DI 697996995SCR8C), active as of 22 Oct 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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697996995SCR8C Basic UDI-DI 06979969951835UDI-DIDate14 Apr 2026RegisteredStatusActive

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  • Withdrawn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

Model / reference
SW01SY
Primary DI / UDI-DI
06979969951835
Basic UDI-DI
697996995SCR8C
EMDN code
Q010280 Prosthetic dentistry devices - accessories
Device class
Class I
EU registration type
Standard device
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000053013
Authorised representative
HyperCert Limited B.V. NL-AR-000047746

Similar devices in this category

Other devices filed under PROSTHETIC DENTISTRY DEVICES - ACCESSORIES.

Other devices from Tianjin Coral Biotechnology Co., Ltd

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Properties

Other properties (14, all answered No)