Identity
- Trade Name
- 104054 DOZ MED. WKŁADKI POD OSTROGI 2 SZT. EUDAMED
- Device Name
- DOZ MED. ZESTAW OSŁON NA STOPY 6 SZT. EUDAMED
- Model / Reference
- 104054 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05905699593190 EUDAMED
- Basic UDI-DI
- 697386485DOZFOOTCAREFZ EUDAMED
- Direct Marketing DI
- 05905699593190 EUDAMED
- EMDN Code
- Y061203 ORTHOSES, FOOT (INCLUDING INSOLES AND INSERTS) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Poland EUDAMED
Clinical & Handling
Sterile
Yes
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
Category: Orthotic insole, prefabricated, non-antimicrobial
104054 Doz Med. Wkładki Pod Ostrogi 2 Szt. by Suzhou Sunmed Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 697386485DOZFOOTCAREFZ | Class I | Active |
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Manufacturer
- Manufacturer
- Suzhou Sunmed Co., Ltd.
- EUDAMED SRN
- CN-MF-000010170
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 3903793e-ae60-4fb6-b217-5b9165d42bbe 61 fields · synced Jun 18, 2026