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Polypro Portable Sleep Diagnostic System
EUDAMEDClass IIa (EU MDR)
Ref H2 PlusRef H2
Identity
- Trade Name
- Polypro Portable Sleep Diagnostic System EUDAMED
- Device Name
- Sleep Apnea Diagnosis Device EUDAMED
- Model / Reference
- H2 Plus EUDAMEDH2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06948538361115 EUDAMED06948538361108 EUDAMED
- Basic UDI-DI
- 69485383SD001T3 EUDAMED
- EMDN Code
- Z12100501 POLYSOMNOGRAPHS EUDAMED
Classification
- Device Class
- Class IIa 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Polypro Portable Sleep Diagnostic System 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 | 69485383SD001T3 | 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 (2)
- EUDAMED 221d48e9-1d15-4653-b789-f6170007db87 61 fields · synced Jul 17, 2026
- EUDAMED f4cfa670-6568-4b27-8f35-662e2e6247b5 61 fields · synced May 18, 2026