← Back to catalogue
AFO Splint
EUDAMEDClass I (EU MDR)
Ref 620001(XL/Right/White)Model AFO Splint 620001 AFO Leaf Spring 620002 Dorsal Night Splint:620016 Night Splint:620003 Soft Night Splint:620004Ref 620001(S/Right/White)Ref 620001(M/Left/White)Ref 620001(XL/Left/White)
Identity
- Trade Name
- AFO Splint EUDAMED
- Device Name
- Ankle Brace, Ankle Foot Orthosis, Night Splint (Ankle/foot orthosis) EUDAMED
- Model / Reference
- AFO Splint 620001 AFO Leaf Spring 620002 Dorsal Night Splint:620016 Night Splint:620003 Soft Night Splint:620004 EUDAMED620001(XL/Right/White) EUDAMED620001(S/Right/White) EUDAMED620001(M/Left/White) EUDAMED620001(XL/Left/White) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719872865568 EUDAMED04719872865544 EUDAMED04719872865513 EUDAMED04719872865551 EUDAMED
- Basic UDI-DI
- 47198728662WN EUDAMED
- EMDN Code
- Y06120601 PASSIVE ANKLE-FOOT ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Greece 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: Ankle/foot orthosis
AFO Splint by Zhangpu Ortholife Rehabilitation Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Ankle/foot orthosis.
- Strp Only, Long, SA Wide Fl 12.5 E Stop — Becker Orthopedic Appliance Company · Class I
- Strp, SFL, 8.25in C Stop , AJT, SA, B — Becker Orthopedic Appliance Company · Class I
- Strp, Spl, WF Cal Pl, AJT, SA B, Free Mot LM/RL — Becker Orthopedic Appliance Company · Class I
- ALIMED ANKLE BRACE ALL AIR TUBE — AliMed, LLC · Class I
- Ankle support with 2 straps - Neoprene - onesize — ΜΙΧΑΛΗΣ ΚΟΥΓΙΟΥΜΤΖΗΣ ΚΑΙ ΣΙΑ Ε.Ε. · Class I
- Rebound® Air Walker LT — Össur Iceland ehf. · Class I
- Strp Blank Insert Only, SA, A/B Size, 3in Free Mot — Becker Orthopedic Appliance Company · Class I
- STABIBOOT 3D — GROUPE SOBER SAS · 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 | 47198728662WN | 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 (4)
- EUDAMED cb26ab37-34d8-4046-a2e3-ab910048c0cd 61 fields · synced Oct 6, 2026
- EUDAMED 420eb529-4e63-45ae-9902-2b9aba8db828 61 fields · synced May 17, 2026
- EUDAMED c76a9970-8776-41f6-a749-82817b14ca60 61 fields · synced May 19, 2026
- EUDAMED 8f2d5a3b-08ac-4b33-bf95-a4f4912d0ec4 61 fields · synced May 19, 2026