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Respiration Data Management Software
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref PAP Link(PC)
Identity
- Trade Name
- Respiration Data Management Software EUDAMEDPAP Link FDA UDI
- Generic Name
- Ventilator application software FDA UDI
- Device Name
- Respiration Data Management Software EUDAMEDPAP Link FDA UDI
- Model / Reference
- PAP Link(PC) EUDAMEDPAP Link PC FDA UDI
- Description
- PAP Link FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06948538369173 EUDAMEDFDA UDI
- Basic UDI-DI
- 69485383DMS01V7 EUDAMED
- Direct Marketing DI
- 06948538369173 EUDAMED
- 510(k) Number
- K242935 FDA UDI
- FDA Product Code
- BZD FDA UDI
- EMDN Code
- Z12159092 VARIOUS PNEUMOLOGY AND RESPIRATORY PHYSIOPATHOLOGY INSTRUMENTS - MEDICAL DEVICE SOFTWARE EUDAMED
- GMDN Term
- Ventilator application software FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 868.5905 FDA UDI
- Special Device Type
- Software EUDAMED
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Respiration Data Management Software by BMC Medical Co., Ltd. — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k)
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K242935 | Class IIa | Active |
| 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 (3)
- EUDAMED ada6d396-4faf-412c-9a8a-a91610c960ef 61 fields · synced Jul 9, 2026
- FDA UDI 1762b9e1-beb0-450a-8e17-0b638c15ea5f 34 fields · synced May 30, 2026
- FDA 510(k) K242935 1 fields · synced May 18, 2026