Identity
- Trade Name
- Multi-attachment for OTV-03 EUDAMEDFUKUDA DENSHI FDA UDI
- Generic Name
- Portable active medical device mount FDA UDI
- Device Name
- Accessories for Sphygmomanometer and Sphygmograph EUDAMED
- Model / Reference
- OAV-10A EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 04538612912351 EUDAMEDFDA UDI
- Basic UDI-DI
- 4538612011019M EUDAMED
- 510(k) Number
- K112521 FDA UDI
- FDA Product Code
- DXN FDA UDI
- EMDN Code
- C9006,Z12050301 EUDAMED
- GMDN Term
- Portable active medical device mount 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Multi-attachment for OTV-03 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 | 4538612011019M | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Fukuda Denshi Co., Ltd.
- EUDAMED SRN
- JP-MF-000008253
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 7d76f8e7-5f30-4de9-9c7e-1e49dd46ffcb 61 fields · synced Jul 24, 2026
- FDA UDI 664dea07-7753-4a6b-9d1b-6a34a39880b9 33 fields · synced May 30, 2026