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W 801-85 / Silicone Breast Form (85 Cm)
EUDAMEDClass I (EU MDR)
Ref W 801-85Model OTHER OTOPEDIC SUPPORT PRODUCTS GROUP
Identity
- Trade Name
- W 801-85 / SILICONE BREAST FORM (85 CM) EUDAMED
- Device Name
- BANDAGES, BRA PADS, ETC. EUDAMED
- Model / Reference
- OTHER OTOPEDIC SUPPORT PRODUCTS GROUP EUDAMEDW 801-85 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08681190365852 EUDAMED
- Basic UDI-DI
- 868119031000FZ EUDAMED
- Direct Marketing DI
- 08681190365852 EUDAMED
- EMDN Code
- V9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Türkiye 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
W 801-85 / Silicone Breast Form (85 Cm) by Doğam Medikal Kozmetik LTD. STI. — 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 | 868119031000FZ | Class I | Active |
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Manufacturer
- Manufacturer
- Doğam Medikal Kozmetik LTD. STI.
- EUDAMED SRN
- TR-MF-000033365
Sources (1)
- EUDAMED 199f639a-e368-4ea7-9d31-76d88dc6d850 61 fields · synced Oct 6, 2026