Identity
- Trade Name
- Ortenika® Taśma do kinezjoterapii EUDAMED
- Device Name
- Bandage EUDAMED
- Model / Reference
- MDR EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06953663104872 EUDAMED06953663120155 EUDAMED
- Basic UDI-DI
- 69536631DL03RK EUDAMED
- EMDN Code
- M0303010201 ELASTIC FIXING BANDAGES, SELF-ADHESIVE, EXTENSIBLE IN ONE DIRECTION EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Poland 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
Ortenika® Taśma do kinezjoterapii by Changzhou DL Medical & Health Equipment Co., 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 | 69536631DL03RK | Class I | Active |
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Manufacturer
- Manufacturer
- Changzhou DL Medical & Health Equipment Co., Ltd.
- EUDAMED SRN
- CN-MF-000010615
- Authorised Representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Sources (2)
- EUDAMED fd7fa1e2-0fa2-4f3d-ac3e-256b66073efb 61 fields · synced Oct 6, 2026
- EUDAMED 1b2681a5-8b27-4ec9-a269-7e682327b4ac 61 fields · synced May 17, 2026