Identity
- Trade Name
- PCG Microphone EUDAMEDFUKUDA DENSHI FDA UDI
- Generic Name
- Cardiac electroacoustic transducer FDA UDI
- Device Name
- Electroacoustic transducer EUDAMED
- Model / Reference
- MA-300 EUDAMEDMA-310HDS(V) EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 04538612040504 EUDAMED04538612914577 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 (3)
- EUDAMED 22d40d05-8c88-4621-a999-fd51734c95ba 61 fields · synced Jul 24, 2026
- EUDAMED ed61a31c-86db-4196-983f-fec0a1cfc093 61 fields · synced May 18, 2026
- FDA UDI cda5cd14-3553-4bca-857b-8cc78e096d1d 33 fields · synced May 30, 2026