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Chest Seal
EUDAMEDClass I (EU MDR)
Ref M186CS03Ref M219-CS01Ref 3311Ref M219-CS02Ref M186-CSTPRef M186-CS01Ref M219-CS04Ref CS001
Identity
- Trade Name
- Chest Seal EUDAMED
- Device Name
- Chest Seal EUDAMED
- Model / Reference
- M186CS03 EUDAMEDM219-CS01 EUDAMED3311 EUDAMEDM219-CS02 EUDAMEDM186-CSTP EUDAMEDM186-CS01 EUDAMEDM219-CS04 EUDAMEDCS001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942455704802 EUDAMED06942455704826 EUDAMED06942455704871 EUDAMED06942455704833 EUDAMED06942455704819 EUDAMED06942455704789 EUDAMED06942455704857 EUDAMED06942455704888 EUDAMED
- Basic UDI-DI
- 697467901DWCST4 EUDAMED
- EMDN Code
- M0499 SPECIAL DRESSINGS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands 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
Category: Scar-management dressing, reusable
Chest Seal by Dragon Medical Co., Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Scar-management dressing, reusable.
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- THERAFOAM — BIODERMIS LLC · Class I
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 | 697467901DWCST4 | Class I | Active |
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Manufacturer
- Manufacturer
- Dragon Medical Co., Ltd
- EUDAMED SRN
- CN-MF-000011438
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (8)
- EUDAMED c40cec8e-3c4f-4c9b-bcf6-9e5d89a63b00 61 fields · synced Aug 2, 2026
- EUDAMED 3a64efd3-4dff-498f-9afc-59bcb478bfdc 61 fields · synced May 17, 2026
- EUDAMED 3735e16f-9b4e-4cca-995c-cb1796bf1367 61 fields · synced May 17, 2026
- EUDAMED 639f1705-511e-414c-891b-fc37dc4fd546 61 fields · synced May 17, 2026
- EUDAMED 118878ce-2a2f-4c65-8b8f-8ff7cd8194a2 61 fields · synced May 17, 2026
- EUDAMED 74bcdb81-7999-4678-a0ce-409af12050f0 61 fields · synced May 17, 2026
- EUDAMED c41dc25b-3429-4a5b-b6f1-c6546aad771e 61 fields · synced May 18, 2026
- EUDAMED 7457b290-edd7-4a1f-a748-7af9e66efe38 61 fields · synced May 18, 2026