Identity
- Trade Name
- Dale Abdominal Binder EUDAMEDFDA UDI
- Generic Name
- Abdominal binder, single-use FDA UDI
- Device Name
- Abdominal Binder EUDAMEDDale Abdominal Binder, 12" wide, stretches to fit 46"-62", 1 per box. FDA UDI
- Model / Reference
- 811 EUDAMEDFDA UDI
- Description
- Dale Abdominal Binder, 12" wide, stretches to fit 46"-62", 1 per box. FDA UDI
Identifiers
- Catalog Number
- 811 FDA UDI
- Primary DI / UDI-DI
- 00817612020414 EUDAMEDFDA UDI
- Basic UDI-DI
- 0817612028116S EUDAMED
- FDA Product Code
- FSD FDA UDI
- EMDN Code
- A108006 ABDOMINAL OSTOMY SUPPORT BELTS EUDAMED
- GMDN Term
- Abdominal binder, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 880.5160 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
Dale Abdominal Binder 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 | 0817612028116S | 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 6a49dbc9-848d-4972-90f4-4e62500bc22b 61 fields · synced Jun 9, 2026
- FDA UDI 5e32321b-7db9-448e-9def-456b54c350e9 35 fields · synced May 30, 2026