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Soft Care

by Bournas Medicals 272 variants

Part of a family of 52 devices: see the family page

Ref 709.080.BL.MRModel DENTAL BIBS

Soft Care (709.080.BL.MR) is a Class I device made by Bournas Medicals, registered in EUDAMED on 5 May 2026 (Basic UDI-DI 5208107108001RM), active as of 24 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 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number5208107108001RM Basic UDI-DI 05208107014127UDI-DIDate5 May 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  • Withdrawn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
DENTAL BIBS, 709.080.BL.MR
Primary DI / UDI-DI
05208107014127
Basic UDI-DI
5208107108001RM
EMDN code
T0306 Patient protection devices during clinical procedures
Device class
Class I
EU registration type
Standard device
EU market of registration
Greece

Manufacturer details

EUDAMED SRN
GR-MF-000023099

Related devices

Category: Radiation/mechanical corneal shield, reusable

Similar devices in this category

Other devices filed under PATIENT PROTECTION DEVICES DURING CLINICAL PROCEDURES.

Other devices from Bournas Medicals

See all devices from Bournas Medicals →

Properties

Other properties (14, all answered No)