Identity
- Trade Name
- Hold-n-Place Legband EUDAMEDDale Foley Catheter Holder FDA UDI
- Generic Name
- Urinary catheter holder FDA UDI
- Device Name
- Foley Catheter Holder EUDAMEDDale Foley Catheter Holder, Legband, fits up to 30" FDA UDI
- Model / Reference
- 316 EUDAMEDFDA UDI
- Description
- Dale Foley Catheter Holder, Legband, fits up to 30" FDA UDI
Identifiers
- Catalog Number
- 316 FDA UDI
- Primary DI / UDI-DI
- 00817612020568 EUDAMEDFDA UDI
- Basic UDI-DI
- 0817612023166B EUDAMED
- FDA Product Code
- EYJ FDA UDI
- EMDN Code
- U0180 URETHRAL PROSTATIC AND BLADDER CATHETERS - ACCESSORIES EUDAMED
- GMDN Term
- Urinary catheter holder FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 876.5130 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
Hold-n-Place Legband 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 | 0817612023166B | 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 7e49e401-0b2b-4100-8437-ca461b8d025c 61 fields · synced Oct 6, 2026
- FDA UDI e8ec6797-7344-4019-b76d-c65d88ce149a 34 fields · synced May 30, 2026