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Pm

by Foshan Nanhai Plus Medical Co., Ltd 2 variants

Part of a family of 6 devices: see the family page

Ref SM-01-MModel SM-01-E SM-01-B SM-01-M SFMW04

Pm (SM-01-M) is a Class I device made by Foshan Nanhai Plus Medical Co., Ltd, registered in EUDAMED on 14 Aug 2023 (Basic UDI-DI 697306232MASK03FG), active as of 23 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 linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697306232MASK03FG Basic UDI-DI 16973062320021UDI-DIDate14 Aug 2023RegisteredStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device name
Medical Face Masks
Model / reference
SM-01-E SM-01-B SM-01-M SFMW04, SM-01-M
Primary DI / UDI-DI
16973062320021
Basic UDI-DI
697306232MASK03FG
EMDN code
T020603 Medical use face masks, type i (not for healthcare professionals)
Device class
Class I
EU registration type
Standard device
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000009816
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Similar devices in this category

Other devices filed under MEDICAL USE FACE MASKS, TYPE I (NOT FOR HEALTHCARE PROFESSIONALS).

Other devices from Foshan Nanhai Plus Medical Co., Ltd

See all devices from Foshan Nanhai Plus Medical Co., Ltd →

Properties

  • Supplied sterile
Other properties (13, all answered No)