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Foldable Skin Closure
EUDAMEDClass IIa (EU MDR)
Ref FS2017Model Foldable Skin Closure 03, Foldable Skin Closure 05, Foldable Skin Closure 09, Foldable Skin Closure 13, Foldable Skin Closure 17, Foldable Skin Closure 21, Foldable Skin Closure 25Ref FS2025Ref FS2021Ref FS2005Ref FS2009
Identity
- Device Name
- Foldable Skin Closure EUDAMED
- Model / Reference
- Foldable Skin Closure 03, Foldable Skin Closure 05, Foldable Skin Closure 09, Foldable Skin Closure 13, Foldable Skin Closure 17, Foldable Skin Closure 21, Foldable Skin Closure 25 EUDAMEDFS2017 EUDAMEDFS2025 EUDAMEDFS2021 EUDAMEDFS2005 EUDAMEDFS2009 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800106200043 EUDAMED08800106200067 EUDAMED08800106200050 EUDAMED08800106200012 EUDAMED08800106200098 EUDAMED08800106200111 EUDAMED
- Basic UDI-DI
- 88001062FSCUU EUDAMED
- EMDN Code
- M0399 BANDAGES - OTHER (see Y06 for collars, tutors, etc.) EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy 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
Foldable Skin Closure by SURGINUS Co., Ltd. — Class IIa — 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 | 88001062FSCUU | Class IIa | Active |
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Manufacturer
- Manufacturer
- SURGINUS Co., Ltd.
- EUDAMED SRN
- KR-MF-000035779
- Authorised Representative
- Javitech Consulting GmbH DE-AR-000045915
Sources (6)
- EUDAMED 4a93177a-de76-40fa-b3c4-9a634db2459a 61 fields · synced Aug 2, 2026
- EUDAMED 5f60b46c-f82c-4799-9afd-036857bbdb1d 61 fields · synced May 17, 2026
- EUDAMED 355057c5-bd85-4e72-943b-c222131bf710 61 fields · synced May 18, 2026
- EUDAMED 9fc4d478-db6c-4d8d-8835-1e4f8fc94026 61 fields · synced May 18, 2026
- EUDAMED 40d8fcd3-4ef8-4bf3-abbf-9b260be0d21b 61 fields · synced Jul 13, 2026
- EUDAMED c652ae9d-6672-42c2-8c7f-804b58898938 61 fields · synced Aug 2, 2026