Identity
- Trade Name
- SYLASET soins sets EUDAMED
- Device Name
- Dressing pack EUDAMED
- Model / Reference
- SP21 EUDAMEDSP35 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977231818343 EUDAMED06977231818428 EUDAMED
- Basic UDI-DI
- 697240330DP00000132 EUDAMED
- EMDN Code
- V0599 CLINICAL PROCEDURES KITS NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France 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
Category: Ophthalmic surgical procedure kit, non-medicated, single-use
SYLASET soins sets by Xuchang Zhende Surgical Dressing Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Ophthalmic surgical procedure kit, non-medicated, single-use.
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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 | 697240330DP00000132 | Class I | Active |
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Manufacturer
- Manufacturer
- Xuchang Zhende Surgical Dressing Co., Ltd
- EUDAMED SRN
- CN-MF-000009222
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED 0b3630b6-d71d-4913-99d1-56f6df5937af 61 fields · synced Oct 6, 2026
- EUDAMED 4c9f8d3e-4ea3-4553-95e6-79de492e4df2 61 fields · synced May 17, 2026