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Novanex
EUDAMEDClass I (EU MDR)
Ref 4x300cm（ skin）Model 2cm x100cm; 2cm x150cm; 3cm x12cm;4cm x7.5cm; 4cm x15cm; 4cm x 150cm; 4cm x 300cm;5cm x30cm; 6cm x7cm; 6cmx12cm
Identity
- Trade Name
- NOVANEX EUDAMED
- Device Name
- SILICONE SCAR TAPE EUDAMED
- Model / Reference
- 2cm x100cm; 2cm x150cm; 3cm x12cm;4cm x7.5cm; 4cm x15cm; 4cm x 150cm; 4cm x 300cm;5cm x30cm; 6cm x7cm; 6cmx12cm EUDAMED4x300cm（ skin） EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06958888002279 EUDAMED
- Basic UDI-DI
- 69588880SiliconeScar86 EUDAMED
- EMDN Code
- M04010203 FIXATION SILICONE DRESSINGS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Novanex by Nantong City Yojo Medical Products Co., Ltd. — 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 | 69588880SiliconeScar86 | Class I | Active |
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Manufacturer
- Manufacturer
- Nantong City YOJO Medical Products Co., Ltd.
- EUDAMED SRN
- CN-MF-000030315
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 1f710860-6b1e-4590-9a60-44d6995e0e8b 61 fields · synced Oct 6, 2026