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
CE MDR
Valid until
No date given
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number471230298PHR7 | Date30 Apr 2026 | StatusActive |
Official records
- EUDAMED public site 471230298PHR7
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- 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
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