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Frejka Splint

by e-life International Co., Ltd. 2 variants

Ref MPHP802 (XL/UNI/GN), MPHP802 (M/UNI/GN), MPHP802 (L/UNI/GN)Model Pavlik Harness Series

Frejka Splint (MPHP802 (XL/UNI/GN)) is a Class I device made by e-life International Co., Ltd., registered in EUDAMED on 30 Apr 2026 (Basic UDI-DI 471230298PHR7), 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 Number471230298PHR7 Basic UDI-DI Date30 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  • Withdrawn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

Device name
Hip orthosis
Model / reference
Pavlik Harness Series, MPHP802 (XL/UNI/GN), MPHP802 (M/UNI/GN), MPHP802 (L/UNI/GN)
Primary DI / UDI-DI
04710374232148, 04710374232124, 04710374232131
Basic UDI-DI
471230298PHR7
EMDN code
Y061215 Hip orthoses (including abduction orthoses)
Device class
Class I
EU registration type
Standard device
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
TW-MF-000009901
Authorised representative
MDSS GmbH DE-AR-000005430

Similar devices in this category

Other devices filed under HIP ORTHOSES (INCLUDING ABDUCTION ORTHOSES).

Other devices from e-life International Co., Ltd.

See all devices from e-life International Co., Ltd. →

Properties

Other properties (14, all answered No)