Identity
- Trade Name
- Dale Bendable Armboard EUDAMEDFDA UDI
- Generic Name
- Armboard, reusable FDA UDI
- Device Name
- Bendable Armboard EUDAMEDDale Bendable Armboard, Small, 4.5" x 1.75" FDA UDI
- Model / Reference
- 652 EUDAMEDFDA UDI
- Description
- Dale Bendable Armboard, Small, 4.5" x 1.75" FDA UDI
Identifiers
- Catalog Number
- 652 FDA UDI
- Primary DI / UDI-DI
- 00817612020322 EUDAMEDFDA UDI
- Basic UDI-DI
- 0817612026526W EUDAMED
- FDA Product Code
- FYH FDA UDI
- EMDN Code
- C010180 PERIPHERAL I.V. CATHETERS AND CANNULAS - ACCESSORIES NOT INCLUDED IN OTHER CLASSES EUDAMED
- GMDN Term
- Armboard, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.3910 FDA UDI
- Market of Registration
- Germany 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
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Conditional FDA UDI
Dale Bendable Armboard by Dale Medical Products, 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 | 0817612026526W | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Dale Medical Products, Inc.
- EUDAMED SRN
- US-MF-000019061
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED 6bd98fe2-4d9f-496c-8157-9654c540fd94 61 fields · synced Oct 6, 2026
- FDA UDI ee9144f0-72d2-43f5-9275-12b17699afac 34 fields · synced May 30, 2026