Identity
- Trade Name
- Oratip I Kit EUDAMEDOratip I Kit Dispoable Oral Evacuation Tips FDA UDI
- Generic Name
- Dental suction system cannula, single-use FDA UDI
- Device Name
- Miscellaneous Class I Dental Accessories EUDAMEDDisposable oral evacuation tips and one Oratip adapter, 72 tips FDA UDI
- Model / Reference
- 24105 EUDAMEDFDA UDI
- Description
- Disposable oral evacuation tips and one Oratip adapter, 72 tips FDA UDI
Identifiers
- Catalog Number
- 24105 FDA UDI
- Primary DI / UDI-DI
- 00310866000138 EUDAMEDFDA UDI
- Basic UDI-DI
- 03108666001GS EUDAMED
- FDA Product Code
- EHZ FDA UDI
- EMDN Code
- Q019001 SALIVA ASPIRATORS AND SALIVA ABSORBENTS EUDAMED
- GMDN Term
- Dental suction system cannula, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.6640 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
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
No
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Oratip I Kit by Pascal Company, 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 | 03108666001GS | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Pascal Company Inc.
- EUDAMED SRN
- US-MF-000032036
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED a2bf683f-93dc-41d0-b1c9-a8004c526d5a 61 fields · synced Jul 14, 2026
- FDA UDI 961fe6c0-0573-4266-83b3-42453276a3fa 35 fields · synced May 30, 2026