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Silicone Gel Scar Dressing
EUDAMEDClass I (EU MDR)
Ref SCARV18Ref SS250100EH-05Ref SS350250E-10Ref SS210120-12Ref 153S-1Ref SCARV10Ref SCARV07 Ref SS076020EH-05Ref SS200050E-10Ref SCARV02Ref SCARV05 Ref SCARV24Ref SCARV27Ref SCARV23Ref SCARV12Ref SS170076EH-05Ref SS075045-12Ref SS200040-12
Identity
- Device Name
- Silicone Gel Scar Dressing EUDAMED
- Model / Reference
- SCARV18 EUDAMEDSS250100EH-05 EUDAMEDSS350250E-10 EUDAMEDSS210120-12 EUDAMED153S-1 EUDAMEDSCARV10 EUDAMEDSCARV07 EUDAMEDSS076020EH-05 EUDAMEDSS200050E-10 EUDAMEDSCARV02 EUDAMEDSCARV05 EUDAMEDSCARV24 EUDAMEDSCARV27 EUDAMEDSCARV23 EUDAMEDSCARV12 EUDAMEDSS170076EH-05 EUDAMEDSS075045-12 EUDAMEDSS200040-12 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06940610133436 EUDAMED06940610108823 EUDAMED06940610108748 EUDAMED06940610105655 EUDAMED26940610112299 EUDAMED06940610133344 EUDAMED06940610133375 EUDAMED06940610108786 EUDAMED06940610108700 EUDAMED06940610133283 EUDAMED06940610133405 EUDAMED06940610133191 EUDAMED06940610133221 EUDAMED06940610133160 EUDAMED06940610133528 EUDAMED06940610108809 EUDAMED06940610108601 EUDAMED06940610124168 EUDAMED
- Basic UDI-DI
- 69406101SS0001D5 EUDAMED69406101SS0013DC EUDAMED
- Unit of Use DI
- 16940610112292 EUDAMED06940610124151 EUDAMED
- EMDN Code
- M0499 SPECIAL DRESSINGS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands EUDAMEDTürkiye EUDAMEDBelgium EUDAMEDNorway 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
Category: Scar-management dressing, reusable
Silicone Gel Scar Dressing by Huizhou Foryou Medical Devices Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Scar-management dressing, reusable.
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- THERAFOAM — BIODERMIS LLC · Class I
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 | 69406101SS0001D5 | Class I | Active |
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Manufacturer
- Manufacturer
- Huizhou Foryou Medical Devices Co., Ltd.
- EUDAMED SRN
- CN-MF-000007344
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (18)
- EUDAMED 287affe8-50bd-4ebd-88c8-fa14cfa9613c 61 fields · synced Sep 17, 2026
- EUDAMED dc5cf263-a5a3-4d80-ae60-8fce71e46202 61 fields · synced May 17, 2026
- EUDAMED 630fe39b-c58b-42f6-8bf7-40858fa17ff6 61 fields · synced May 17, 2026
- EUDAMED 469e18e1-f14d-4f33-a895-d9773b7e6c4c 61 fields · synced May 17, 2026
- EUDAMED f8ffa20c-d08e-4a43-8626-1d186f43539a 61 fields · synced May 17, 2026
- EUDAMED 84fa5634-46f9-4be6-ac14-f4f356723dee 61 fields · synced May 17, 2026
- EUDAMED a062a917-1327-4a71-b2d5-f60a6b519665 61 fields · synced May 17, 2026
- EUDAMED ac0f1a52-b5ea-4e37-9d86-b25daf4c20ef 61 fields · synced May 18, 2026
- EUDAMED 7be152be-089a-4e96-af72-5644c660e242 61 fields · synced May 18, 2026
- EUDAMED 30818dba-6d6a-4c60-9020-9a26172bde48 61 fields · synced May 18, 2026
- EUDAMED b87d8426-4cc2-4057-9db3-1c5f624beb5f 61 fields · synced May 18, 2026
- EUDAMED f79c440b-a23c-461d-8ff8-1da469c98885 61 fields · synced May 18, 2026
- EUDAMED 5ba15cc4-9552-4409-9aa2-2ea29401ea51 61 fields · synced May 18, 2026
- EUDAMED ac98a4a0-71f6-42d5-bbe8-c800988dd3b3 61 fields · synced May 19, 2026
- EUDAMED 8f19025d-ef70-4b57-9f42-51933711e3c6 61 fields · synced May 19, 2026
- EUDAMED 3e6a57bb-270c-4bfa-b769-49b95ab0fe72 61 fields · synced May 19, 2026
- EUDAMED 86c6a17f-760d-4258-82a2-386a09769ba9 61 fields · synced May 19, 2026
- EUDAMED b07d0a3e-2763-4c8b-9c4c-9d3e2c18a456 61 fields · synced Aug 2, 2026