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Foldable Skin Closure
EUDAMEDClass IIa (EU MDR)
Ref FS2003Model 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
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 EUDAMEDFS2003 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800106200135 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 (1)
- EUDAMED a0077f2d-1357-408c-a7c5-7b680c032dff 61 fields · synced Jun 18, 2026