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Disposable Dry Seal Chest Drainage Systems
EUDAMEDClass IIa (EU MDR)
Ref AFG31-3 100003750Model AFG31-3Ref AFG31-2 100003749Model AFG31-2Ref AFG31-1 100003748Model AFG31-1
Identity
- Trade Name
- Disposable Dry Seal Chest Drainage Systems EUDAMED
- Device Name
- Disposable Dry Seal Chest Drainage Systems EUDAMED
- Model / Reference
- AFG31-3 EUDAMEDAFG31-3 100003750 EUDAMEDAFG31-2 EUDAMEDAFG31-2 100003749 EUDAMEDAFG31-1 EUDAMEDAFG31-1 100003748 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971944913173 EUDAMED06971944913166 EUDAMED06971944913159 EUDAMED
- Basic UDI-DI
- 697194491AFG31-3HL EUDAMED697194491AFG31-2HJ EUDAMED697194491AFG31-1HG EUDAMED
- EMDN Code
- A06010199 VACUUM AND GRAVITY DRAINAGE SYSTEMS - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Spain 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
Disposable Dry Seal Chest Drainage Systems by Ningbo Xinwell Medical Technology 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 | 697194491AFG31-3HL | Class IIa | Active |
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Manufacturer
- Manufacturer
- Ningbo Xinwell Medical Technology Co., Ltd
- EUDAMED SRN
- CN-MF-000001084
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (3)
- EUDAMED f277524d-80eb-41a1-825d-0c13c5992b65 61 fields · synced Aug 3, 2026
- EUDAMED f5f0dafa-e597-4d2d-9151-9232fb242990 61 fields · synced May 18, 2026
- EUDAMED 60a454b9-7753-4cac-b27d-7fed27e2630a 61 fields · synced May 18, 2026