Identity
- Trade Name
- NIBP / Pulse Wave Unit EUDAMEDFUKUDA DENSHI FDA UDI
- Generic Name
- Noninvasive multiple cardiovascular measurement unit FDA UDI
- Device Name
- Sphygmomanometer and Sphygmograph EUDAMED
- Model / Reference
- BPU-100 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 04538612912412 EUDAMED04538612912658 FDA UDI
- Basic UDI-DI
- 4538612011009K EUDAMED
- 510(k) Number
- K112521 FDA UDI
- FDA Product Code
- DXN FDA UDI
- EMDN Code
- C9006,Z12050301 EUDAMED
- GMDN Term
- Noninvasive multiple cardiovascular measurement unit FDA UDI
Classification
- Device Class
- Class IIa 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
Yes
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
Yes
FDA UDI
NIBP / Pulse Wave Unit by Fukuda Denshi Co., Ltd. — Class IIa — 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 | 4538612011009K | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | 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 0357a948-a30e-4a0d-9573-e98a53fe6e5e 61 fields · synced Jun 18, 2026
- FDA UDI b18021c0-a2a1-4ac0-b534-038312b61e3d 33 fields · synced May 30, 2026