Identity
- Trade Name
- Ortho insert EUDAMED
- Device Name
- Ortho insert EUDAMED
- Model / Reference
- Ortho insert EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976340060049 EUDAMED
- Basic UDI-DI
- 697634006004J5 EUDAMED
- EMDN Code
- T0499 INCONTINENCE DEVICES - OTHER 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
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
Ortho insert by Dongguan Jinyang Sporting Goods 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 | 697634006004J5 | Class I | Active |
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Manufacturer
- Manufacturer
- Dongguan Jinyang Sporting Goods Co, . Ltd
- EUDAMED SRN
- CN-MF-000035236
- Authorised Representative
- Everbiz GmbH DE-AR-000008964
Sources (1)
- EUDAMED 795d516f-f113-446d-8455-aaa3988d4684 61 fields · synced Jul 11, 2026