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Medical Dressings
EUDAMEDClass I (EU MDR)
Ref MDN 1204 Model D2030Ref 1204Model D/Surgical Films
Identity
- Trade Name
- Medical Dressings EUDAMEDMedical Dressings--Surgical Films EUDAMED
- Device Name
- Medical Dressings EUDAMED
- Model / Reference
- D2030 EUDAMEDMDN 1204 EUDAMEDD/Surgical Films EUDAMED1204 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16975670551613 EUDAMED
- Basic UDI-DI
- B-16975670551613 EUDAMED697567055ddressingsBF EUDAMED
- Direct Marketing DI
- 16975670551613 EUDAMED
- EMDN Code
- M04010202 POLYURETHANE FIXING DRESSINGS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Hungary 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
Medical Dressings by Shandong Shingna Medical Products Co., Ltd. — Class I — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-16975670551613 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-16975670551613 | Class I | Active |
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Manufacturer
- Manufacturer
- Shandong Shingna Medical Products Co., Ltd.
- EUDAMED SRN
- CN-MF-000001937
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (2)
- EUDAMED 5bebfcc5-ae31-4c83-a3c9-395dce0a0ed0 61 fields · synced Jun 19, 2026
- EUDAMED 6526a440-2c71-4ab8-b7c9-a303019110be 61 fields · synced May 19, 2026