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Ultra Boot - Size 4 (Pair)
EUDAMEDClass I (EU MDR)
Ref ULTB-4Model ULTB
by Chaneco Ltd
Identity
- Trade Name
- Ultra Boot - Size 4 (Pair) EUDAMED
- Device Name
- Ultra Boot EUDAMED
- Model / Reference
- ULTB EUDAMEDULTB-4 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05056157606539 EUDAMED
- Basic UDI-DI
- 50561576UltraBootRL EUDAMED
- EMDN Code
- Y063303 READY-MADE ORTHOTIC SHOES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Ireland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
Yes
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
Ultra Boot - Size 4 (Pair) by Chaneco Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 50561576UltraBootRL | Class I | Active |
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Manufacturer
- Manufacturer
- Chaneco Ltd
- EUDAMED SRN
- UK-MF-000043937
- Authorised Representative
- UKALIA Limited XI-AR-000024526
Sources (1)
- EUDAMED e7843f0b-16ad-4ed0-bd0a-8ad0ce30948a 61 fields · synced Jun 20, 2026