Identity
- Trade Name
- Toe Cuff Cover OA-459M EUDAMEDFUKUDA DENSHI FDA UDI
- Generic Name
- Patient examination/treatment drape, single-use FDA UDI
- Device Name
- Accessories for Sphygmomanometer and Sphygmograph EUDAMED
- Model / Reference
- OA-459M EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 04538612312243 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
- Patient examination/treatment drape, single-use 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
Yes
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
Yes
FDA UDI
Toe Cuff Cover OA-459M 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 |
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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 03f3ab25-5cd9-44ee-818c-6eadb78741aa 61 fields · synced Jun 18, 2026
- FDA UDI 76fb81a2-a736-45b1-83da-8122cdf11669 33 fields · synced May 29, 2026