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Disposable Pressure Transducer
EUDAMEDFDA 510(k)Class IIb (EU MDR)
Ref DBPT-0830C10510(k) K152472
Identity
- Trade Name
- Disposable Pressure Transducer EUDAMED
- Device Name
- Disposable Pressure Transducer EUDAMED
- Model / Reference
- DBPT-0830C10 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06944375391247 EUDAMED
- Basic UDI-DI
- B-06944375391247 EUDAMED
- EMDN Code
- Z1203020301 INVASIVE BLOOD PRESSURE MONITORING INSTRUMENTS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Czechia EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: In-line arterial blood sampling set
Disposable Pressure Transducer by Zhejiang Haisheng Medical Device Co., Ltd. — Class IIb — FDA_510K, MDD — listed in EUDAMED, FDA 510(k)
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Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K152472 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-06944375391247 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Zhejiang Haisheng Medical Device Co., Ltd.
- EUDAMED SRN
- CN-MF-000026345
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED 800d7a97-cb59-40ad-9b0b-aa4a43bf6159 85 fields · synced Jun 18, 2026
- FDA 510(k) K152472 1 fields · synced May 18, 2026