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Diawin D3 Serene
EUDAMEDClass I (EU MDR)
Ref FF45391Model DIAWIN-D3-SERENERef FF45392Ref FF45482Ref FF45431Ref FF45502Ref FF45463Ref FF45373Ref FF45441Ref FF45451Ref FF45492Ref FF45363Ref FF45401Ref FF45402Ref FF45381Ref FF45383Ref FF45461Ref FF45491Ref FF45442Ref FF45462Ref FF45433Ref FF45403Ref FF45382Ref FF45443Ref FF45453Ref FF45473Ref FF45481Ref FF45503
Identity
- Device Name
- DIAWIN D3 SERENE EUDAMED
- Model / Reference
- DIAWIN-D3-SERENE EUDAMEDFF45391 EUDAMEDFF45392 EUDAMEDFF45482 EUDAMEDFF45431 EUDAMEDFF45502 EUDAMEDFF45463 EUDAMEDFF45373 EUDAMEDFF45441 EUDAMEDFF45451 EUDAMEDFF45492 EUDAMEDFF45363 EUDAMEDFF45401 EUDAMEDFF45402 EUDAMEDFF45381 EUDAMEDFF45383 EUDAMEDFF45461 EUDAMEDFF45491 EUDAMEDFF45442 EUDAMEDFF45462 EUDAMEDFF45433 EUDAMEDFF45403 EUDAMEDFF45382 EUDAMEDFF45443 EUDAMEDFF45453 EUDAMEDFF45473 EUDAMEDFF45481 EUDAMEDFF45503 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08585074600544 EUDAMED08585074600551 EUDAMED08585074600827 EUDAMED08585074600667 EUDAMED08585074600889 EUDAMED08585074600773 EUDAMED08585074600506 EUDAMED08585074600698 EUDAMED08585074600728 EUDAMED08585074600858 EUDAMED08585074600476 EUDAMED08585074600575 EUDAMED08585074600582 EUDAMED08585074600513 EUDAMED08585074600537 EUDAMED08585074600759 EUDAMED08585074600841 EUDAMED08585074600704 EUDAMED08585074600766 EUDAMED08585074600681 EUDAMED08585074600599 EUDAMED08585074600520 EUDAMED08585074600711 EUDAMED08585074600742 EUDAMED08585074600803 EUDAMED08585074600810 EUDAMED08585074600896 EUDAMED
- Basic UDI-DI
- 85850746FF45T9 EUDAMED
- EMDN Code
- Y063303 READY-MADE ORTHOTIC SHOES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Czechia 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
Diawin D3 Serene by Diawin s.r.o. — 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 | 85850746FF45T9 | Class I | Active |
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Manufacturer
- Manufacturer
- Diawin s.r.o.
- EUDAMED SRN
- SK-MF-000048596
Sources (27)
- EUDAMED e06f45cb-5b09-4053-bfaf-3105cb6d42a3 61 fields · synced Oct 6, 2026
- EUDAMED 4f386849-ff65-44cf-9d3a-a2b991a4f279 61 fields · synced May 16, 2026
- EUDAMED 41eada62-4fba-4e48-ae98-4a3f9009bc13 61 fields · synced May 16, 2026
- EUDAMED 2ea4d56f-b0bf-492e-94d3-78a2155d4eea 61 fields · synced May 16, 2026
- EUDAMED ffd9d0fb-0d04-4b07-82ed-19a958cdc329 61 fields · synced May 16, 2026
- EUDAMED 2bfdbeb6-1c40-4a4a-960d-8661ad4f3b79 61 fields · synced May 16, 2026
- EUDAMED 980dbb84-2ab4-4d90-89ef-2a7b458678bb 61 fields · synced May 16, 2026
- EUDAMED d3be9823-1e86-47bc-abea-8b19a66828a8 61 fields · synced May 16, 2026
- EUDAMED 366ebc0a-164e-4408-ba5c-632cba42bc75 61 fields · synced May 17, 2026
- EUDAMED 54881116-0a90-4c6d-b7a6-25794d9e0623 61 fields · synced May 17, 2026
- EUDAMED 9b5320cc-7004-42f9-afd0-fb4b9b417e72 61 fields · synced May 17, 2026
- EUDAMED 370283ef-ebe7-46e6-9325-ab6011640d59 61 fields · synced May 17, 2026
- EUDAMED cc00d7aa-1884-47f4-956e-7e4ba48c6d14 61 fields · synced May 17, 2026
- EUDAMED 33091fab-5428-4033-90ac-560e16bfad69 61 fields · synced May 17, 2026
- EUDAMED 14355630-7cf5-4822-846d-55a2dac2952c 61 fields · synced May 18, 2026
- EUDAMED 3919dfb5-4fe1-42f8-8a26-55160a4e4c68 61 fields · synced May 18, 2026
- EUDAMED 404b92cf-6aa2-42d9-b02e-695a8af4ddd7 61 fields · synced May 18, 2026
- EUDAMED 849dcd64-a465-4630-84b6-9d3273ebc85e 61 fields · synced May 18, 2026
- EUDAMED 8aaf1cda-8f9a-40d6-87ff-0f0d3b6b4592 61 fields · synced May 18, 2026
- EUDAMED 75373a2a-5e02-455c-945e-eb986a1620d4 61 fields · synced May 18, 2026
- EUDAMED 7901dcf6-7519-42ef-819d-fedaee101272 61 fields · synced May 18, 2026
- EUDAMED acda75a2-0b77-4bd5-ae85-fda2cc786bb0 61 fields · synced May 18, 2026
- EUDAMED a76eea16-9b80-460e-b508-cb687572413c 61 fields · synced May 18, 2026
- EUDAMED 3a585026-0908-459a-9100-1610df034d53 61 fields · synced May 18, 2026
- EUDAMED 96d2e46c-37a1-4752-a421-08aa6367dd97 61 fields · synced May 19, 2026
- EUDAMED ec304d0d-69be-47bd-ac15-ad2feb7530bb 61 fields · synced May 19, 2026
- EUDAMED 3dcb6da2-0a14-481e-9304-5682636cc285 61 fields · synced May 19, 2026