Identity
- Trade Name
- Hokanson FDA UDI
- Generic Name
- Blood pressure cuff, reusable FDA UDI
- Device Name
- Custom digit vascular cuff EUDAMEDFDA UDI
- Model / Reference
- UDCXXS EUDAMEDUDCXXS™ FDA UDI
- Description
- Custom digit vascular cuff FDA UDI
Identifiers
- Catalog Number
- 43055 FDA UDI
- Primary DI / UDI-DI
- 00817065021839 EUDAMEDFDA UDI
- Basic UDI-DI
- 00817065021839EC EUDAMED
- 510(k) Number
- K041689 FDA UDI
- FDA Product Code
- DXQ FDA UDI
- EMDN Code
- Z1203020599 NON-INVASIVE BLOOD PRESSURE GAUGES - OTHER EUDAMED
- GMDN Term
- Blood pressure cuff, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 870.1120 FDA UDI
- Market of Registration
- Netherlands 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
Yes
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Custom digit vascular cuff by D. E. Hokanson, Inc. — 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 | 00817065021839EC | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- D. E. Hokanson, Inc.
- EUDAMED SRN
- US-MF-000007949
- Authorised Representative
- MedEnvoy Global BV NL-AR-000024028
Sources (2)
- EUDAMED a1f28fac-91e8-4127-982c-8151f5b78e98 61 fields · synced Jul 11, 2026
- FDA UDI b7718823-706a-4591-b5db-75e11729417c 36 fields · synced May 30, 2026