Identity
- Trade Name
- Dale Scrape-n-Suction Tongue Cleaner EUDAMEDFDA UDI
- Generic Name
- Tongue scraper, single-use FDA UDI
- Device Name
- Dale Scrape-n-Suction Tongue Cleaner EUDAMEDThe Dale Scrape-n-Suction Tongue Cleaner is a plastic device with a hollow core that allows it to be attached to a vacuum source to remove biofilm from the tongue. FDA UDI
- Model / Reference
- 220 EUDAMEDFDA UDI
- Description
- The Dale Scrape-n-Suction Tongue Cleaner is a plastic device with a hollow core that allows it to be attached to a vacuum source to remove biofilm from the tongue. FDA UDI
Identifiers
- Catalog Number
- 220 FDA UDI
- Primary DI / UDI-DI
- 00817612021008 EUDAMEDFDA UDI
- Basic UDI-DI
- 0817612022205V EUDAMED
- FDA Product Code
- LCN FDA UDI
- EMDN Code
- V80 CLINICAL USE ACCESSORIES NOT INCLUDED IN OTHER CLASSES EUDAMED
- GMDN Term
- Tongue scraper, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.6855 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 Scrape-n-Suction Tongue Cleaner 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 | 0817612022205V | 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 57dd0d6c-714a-4e98-9ee7-3e49023ab0ab 61 fields · synced Oct 6, 2026
- FDA UDI 713ff3d3-52e3-4530-ae39-9ecca1c24a95 34 fields · synced May 30, 2026