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Chest Seal
EUDAMEDClass I (EU MDR)
Ref AZ-CSC-02Model AZ-CSN-01,AZ-CSN-02,AZ-CSN-03,AZ-CSV-01,AZ-CSV-02,AZ-CSV-03,AZ-CSC-01,AZ-CSC-02,AZ-CSC-03,AZ-CSD-01,AZ-CSD-02,AZ-CSD-03
Identity
- Trade Name
- Chest Seal EUDAMED
- Device Name
- Chest Seal EUDAMED
- Model / Reference
- AZ-CSN-01,AZ-CSN-02,AZ-CSN-03,AZ-CSV-01,AZ-CSV-02,AZ-CSV-03,AZ-CSC-01,AZ-CSC-02,AZ-CSC-03,AZ-CSD-01,AZ-CSD-02,AZ-CSD-03 EUDAMEDAZ-CSC-02 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973105232376 EUDAMED
- Basic UDI-DI
- 697310523ChestSealED EUDAMED
- EMDN Code
- M04010101 NON-WOVEN ADHESIVE DRESSINGS, WITH ABSORBENT PAD EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Chest Seal by Anping Guardian Medical Equipment 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 | 697310523ChestSealED | Class I | Active |
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Manufacturer
- Manufacturer
- Anping Guardian Medical Equipment Co., Ltd
- EUDAMED SRN
- CN-MF-000015025
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (1)
- EUDAMED 96155695-dd1e-40e2-8aaf-a8f9bbe82f6b 61 fields · synced Jun 19, 2026