Identity
- Trade Name
- Dale Nasal Dressing Holder EUDAMEDFDA UDI
- Generic Name
- Non-adhesive device retention bandage FDA UDI
- Device Name
- Nasal Dressing Holder EUDAMEDDale Nasal Dressing Holder, Fits most FDA UDI
- Model / Reference
- 600 EUDAMEDFDA UDI
- Description
- Dale Nasal Dressing Holder, Fits most FDA UDI
Identifiers
- Catalog Number
- 600 FDA UDI
- Primary DI / UDI-DI
- 00817612020827 EUDAMEDFDA UDI
- Basic UDI-DI
- 0817612026006B EUDAMED
- FDA Product Code
- KGX FDA UDI
- EMDN Code
- M040299 NON-ADHESIVE ABSORBENT DRESSINGS - OTHER EUDAMED
- GMDN Term
- Non-adhesive device retention bandage FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 880.5240 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 Nasal Dressing Holder 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 | 0817612026006B | 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 d754a2e0-b628-44e6-a073-6ebc12f6b4a6 61 fields · synced Jun 9, 2026
- FDA UDI 34d57dc8-9a34-4ac6-b65d-c8bd932139a0 35 fields · synced May 30, 2026