Identity
- Trade Name
- Ear Loop EUDAMED
- Device Name
- BILLEAU LOOP, SMALL 1.5x3MM EUDAMED
- Model / Reference
- C4 107 01 EUDAMEDC4 107 02 EUDAMEDC4 107 03 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08961102700606 EUDAMED08961102700613 EUDAMED
- Basic UDI-DI
- 896110270ZI0707EL90080Y7 EUDAMED
- EMDN Code
- L149099 ENT INSTRUMENTS, REUSABLE - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
Ear Loop by Ziana Industries — 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 | 896110270ZI0707EL90080Y7 | Class I | Active |
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Manufacturer
- Manufacturer
- Ziana Industries
- EUDAMED SRN
- PK-MF-000011900
- Authorised Representative
- International Business Compendious of Sweden SE-AR-000001625
Sources (2)
- EUDAMED 03e824b0-33b2-46a8-8039-276b86f6ff8a 61 fields · synced Jul 26, 2026
- EUDAMED e0d11871-9637-4539-979b-5c83a1f41400 61 fields · synced May 18, 2026