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Bouffant cap

by Ningbo Transo-Medical Co., Ltd. 3 variants

Part of a family of 7 devices: see the family page

Ref 3230TModel TM01

Bouffant cap (3230T) is a Class I device made by Ningbo Transo-Medical Co., Ltd., registered in EUDAMED on 7 Jan 2025 (Basic UDI-DI 697461841TM01NT), 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 Number697461841TM01NT Basic UDI-DI 06974618411753UDI-DIDate7 Jan 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  • Withdrawn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
Caps
Model / reference
TM01, 3230T
Primary DI / UDI-DI
06974618411753
Basic UDI-DI
697461841TM01NT
EMDN code
T0207 Caps and headwear (excluding personal protective equipment - PPE)
Device class
Class I
EU registration type
Standard device
EU market of registration
Sweden

Manufacturer details

EUDAMED SRN
CN-MF-000009687
Authorised representative
Caretechion GmbH DE-AR-000005946

Similar devices in this category

Other devices filed under CAPS AND HEADWEAR (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT - PPE).

Other devices from Ningbo Transo-Medical Co., Ltd.

See all devices from Ningbo Transo-Medical Co., Ltd. →

Properties

Other properties (14, all answered No)