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PANTORRILLERA ELASTICA - Elastic Calf Support
EUDAMEDClass I (EU MDR)
Ref ACE804#1
Identity
- Trade Name
- PANTORRILLERA ELASTICA ; ELASTIC CALF SUPPORT EUDAMED
- Device Name
- Ortesis de pantorrilla - Elásticas EUDAMED
- Model / Reference
- ACE804#1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08435025981447 EUDAMED
- Basic UDI-DI
- 84350259ORL20412PT EUDAMED
- EMDN Code
- Y061299 LOWER EXTREMITY ORTHOSES - OTHER EUDAMED
- Models / Variants
- Pantorrillera Elastica EUDAMEDElastic Calf Support EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain 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
PANTORRILLERA ELASTICA - Elastic Calf Support by Orliman, S.L.U. — Class I — MDR — listed in EUDAMED — 2 models — 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 | 84350259ORL20412PT | Class I | Active |
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Manufacturer
- Manufacturer
- Orliman, S.L.U.
- EUDAMED SRN
- ES-MF-000001598
Sources (1)
- EUDAMED b3ee6640-110b-4150-bea5-a9034fd60764 61 fields · synced Jun 19, 2026