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Reswell
EUDAMEDClass IIa (EU MDR)
Ref RVC830ARef RVC830Ref RVTH200Ref RVTH001Ref RVTH202AT
Identity
- Trade Name
- RESWELL EUDAMED
- Device Name
- Continuous Positive Airway Pressure Units EUDAMEDHeated Tube EUDAMED
- Model / Reference
- RVC830A EUDAMEDRVC830 EUDAMEDRVTH200 EUDAMEDRVTH001 EUDAMEDRVTH202AT EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06944290671004 EUDAMED06944290670007 EUDAMED06944290679321 EUDAMED16944290680003 EUDAMED06944290679116 EUDAMED16944290671001 EUDAMED06944290679000 EUDAMED16944290671049 EUDAMED
- Basic UDI-DI
- B-06944290671004 EUDAMEDB-06944290670007 EUDAMEDB-06944290679321 EUDAMEDB-16944290680003 EUDAMEDB-06944290679116 EUDAMEDB-16944290671001 EUDAMEDB-06944290679000 EUDAMEDB-16944290671049 EUDAMED
- EMDN Code
- Z12030102 CONTINUOUS POSITIVE PRESSURE EQUIPMENT EUDAMEDR02010401,R020107 EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDEUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Reswell by Beijing Rongrui-Century Science & Technology Co. , Ltd. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06944290671004 | Class IIa | Active |
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Manufacturer
- EUDAMED SRN
- CN-MF-000015303
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (8)
- EUDAMED 5173380a-fee7-47e7-8abf-3ae6bf061311 61 fields · synced Oct 6, 2026
- EUDAMED d72a12fd-228a-4b07-93ac-83746c118ddc 61 fields · synced May 18, 2026
- EUDAMED 06f24ace-18c9-4785-aa3f-963ea1a53d09 61 fields · synced May 18, 2026
- EUDAMED 6057953c-7e69-4542-98ce-ded6b51d851a 61 fields · synced May 18, 2026
- EUDAMED af202bb9-6890-427d-9a36-66ce862f7b99 61 fields · synced May 18, 2026
- EUDAMED 79aabd78-d1e9-46d1-85bf-2ff43c49806b 61 fields · synced May 19, 2026
- EUDAMED 5b7d52d3-6e94-4e6e-9b14-9fccca8a1bf2 61 fields · synced May 19, 2026
- EUDAMED 5506c0fa-2385-42c6-b47d-58054ca3bb1c 61 fields · synced May 19, 2026