Identity
- Trade Name
- Toe Separator EUDAMED
- Device Name
- Insole (Hallux valgus metatarsophalangeal orthosis and toe separator) EUDAMED
- Model / Reference
- 650009(M/UNI/White) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719872867067 EUDAMED
- Basic UDI-DI
- 47198728665WU EUDAMED
- EMDN Code
- Y061203 ORTHOSES, FOOT (INCLUDING INSOLES AND INSERTS) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Orthotic insole, prefabricated, non-antimicrobial
Toe Separator by Zhangpu Ortholife Rehabilitation Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Orthotic insole, prefabricated, non-antimicrobial.
- SIFTAL — LABORATORIOS HERBITAS, S.L. · Class I
- HAPAD MEDIAL/LATERAL HEEL PADS — Hapad, Inc · Class I
- Passive Ankle-Foot Orthoses — Mammon International Corp. · Class I
- TALONNETTE FEET PAD AVEC INSERT LATERAL T3 (VENDU PAR PAIRE) — Orliman, S.L.U. · Class I
- ESTCARBON — Erismet OU · Class I
- BA 702-26 — BİOAKTİF TIBBİ ÜRÜNLER VE TEKNİK TEKSTİL SAN. TİC. LTD. ŞTİ. · Class I
- Medisole Forefoot Women size 39 — Dumco B.V. · Class I
- MEDI — MEDI MANUFACTURING, INC. · Class I
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 47198728665WU | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Zhangpu Ortholife Rehabilitation Co., Ltd.
- EUDAMED SRN
- CN-MF-000011447
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 9e0aa64a-b17a-4600-bcbd-9bdf18eda300 61 fields · synced Jun 18, 2026