Identity
- Trade Name
- Tynor EUDAMED
- Device Name
- BREAST PROSTHESES, EXTERNAL EUDAMED
- Model / Reference
- H 19 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08903424735843 EUDAMED
- Basic UDI-DI
- 8903424BPE063018JJ EUDAMED
- Direct Marketing DI
- 08903424735843 EUDAMED
- EMDN Code
- Y063018 EXTERNAL BREAST PROSTHESES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Denmark 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
Tynor by Tynor Orthotics Pvt 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 | 8903424BPE063018JJ | Class I | Active |
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Manufacturer
- Manufacturer
- Tynor Orthotics Pvt Ltd
- EUDAMED SRN
- IN-MF-000005705
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (1)
- EUDAMED 2cec1ea2-c130-4a8e-8752-b4492301e8d0 61 fields · synced Jun 19, 2026