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Masque Chirurgical

by Shandong Intco Medical Products Co., Ltd.

Part of a family of 14 devices: see the family page

Ref FM 301

Masque Chirurgical (FM 301) is a Class I device made by Shandong Intco Medical Products Co., Ltd., registered in EUDAMED on 5 Dec 2023 (Basic UDI-DI 697024575FMYN), 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 Number697024575FMYN Basic UDI-DI 06970245751330UDI-DIDate5 Dec 2023RegisteredStatusActive

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  • Withdrawn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
Medical Face Mask
Model / reference
FM 301
Primary DI / UDI-DI
06970245751330
Basic UDI-DI
697024575FMYN
EMDN code
T020604 Medical use face masks, type II and iir
Device class
Class I
System or procedure pack
System which is a device in itself
EU registration type
Standard device
EU market of registration
France

Manufacturer details

EUDAMED SRN
CN-MF-000002100
Authorised representative
Lotus NL B.V. NL-AR-000000121

Similar devices in this category

Other devices filed under MEDICAL USE FACE MASKS, TYPE II AND IIR.

Other devices from Shandong Intco Medical Products Co., Ltd.

See all devices from Shandong Intco Medical Products Co., Ltd. →

Properties

Other properties (14, all answered No)