Identity
- Trade Name
- PCG Microphone EUDAMEDFUKUDA DENSHI FDA UDI
- Generic Name
- Cardiac electroacoustic transducer FDA UDI
- Device Name
- Electroacoustic transducer EUDAMED
- Model / Reference
- MA-300HDS(V) EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 04538612914560 EUDAMEDFDA UDI
- Basic UDI-DI
- 453861203300AB EUDAMED
- 510(k) Number
- K112521 FDA UDI
- FDA Product Code
- DXN FDA UDI
- EMDN Code
- C020599 CARDIAC DIAGNOSTIC DEVICES - OTHER EUDAMED
- GMDN Term
- Cardiac electroacoustic transducer FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 870.1130 FDA UDI
- Market of Registration
- Italy 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
No
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
PCG Microphone by Fukuda Denshi Co., Ltd. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 453861203300AB | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Fukuda Denshi Co., Ltd.
- EUDAMED SRN
- JP-MF-000008253
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 41e09ca5-7002-48ba-afcd-d89e7b5a13d8 61 fields · synced Jul 29, 2026
- FDA UDI b2a975ab-6647-44fc-bd7a-4b0068ce2caa 33 fields · synced May 29, 2026