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Respiration Data Management Software
EUDAMEDClass IIa (EU MDR)
Ref PAP Link(Web)
Identity
- Trade Name
- Respiration Data Management Software EUDAMED
- Device Name
- Respiration Data Management Software EUDAMED
- Model / Reference
- PAP Link(Web) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06948538369159 EUDAMED
- Basic UDI-DI
- 69485383DMS01V7 EUDAMED
- Direct Marketing DI
- 06948538369159 EUDAMED
- EMDN Code
- Z12159092 VARIOUS PNEUMOLOGY AND RESPIRATORY PHYSIOPATHOLOGY INSTRUMENTS - MEDICAL DEVICE SOFTWARE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Special Device Type
- Software EUDAMED
- Market of Registration
- Germany 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
Respiration Data Management Software by BMC Medical 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 | 69485383DMS01V7 | Class IIa | Active |
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Manufacturer
- Manufacturer
- BMC Medical Co., Ltd.
- EUDAMED SRN
- CN-MF-000010157
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 813ca6ad-6ea2-47c2-b2a2-8ff1fa35dcf0 61 fields · synced Jun 19, 2026