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Irrigation Tips(end Open Type)
EUDAMEDFDA UDIClass I (EU MDR)
Ref 951-201AModel IRRIGATION TIPS(END OPEN TYPE) 18G
Identity
- Trade Name
- IRRIGATION TIPS(END OPEN TYPE) EUDAMEDIrrigation Tip FDA UDI
- Generic Name
- Root canal irrigation blunt needle FDA UDI
- Device Name
- IRRIGATION TIPS(END OPEN TYPE) EUDAMEDThis device connected with manually-operated syringe only is used in order to spray oral cavity with cleansing fluid. FDA UDI
- Model / Reference
- IRRIGATION TIPS(END OPEN TYPE) 18G EUDAMED951-201A EUDAMEDEND OPEN TYPE 18G FDA UDI
- Description
- This device connected with manually-operated syringe only is used in order to spray oral cavity with cleansing fluid. FDA UDI
Identifiers
- Catalog Number
- 951-201 FDA UDI
- Primary DI / UDI-DI
- 08806383562461 EUDAMEDFDA UDI
- Basic UDI-DI
- 88063835IRN5H EUDAMED
- FDA Product Code
- JEW FDA UDI
- EMDN Code
- A010602 DENTAL IRRIGATION NEEDLES EUDAMED
- GMDN Term
- Root canal irrigation blunt needle FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.6650 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
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Irrigation Tips(end Open Type) by Diadent Group International — 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 | 88063835IRN5H | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Diadent Group International
- EUDAMED SRN
- KR-MF-000023806
- Authorised Representative
- Diadent Europe B.V. NL-AR-000012597
Sources (2)
- EUDAMED 435d4f79-a96d-4d25-8d78-d01caee19511 61 fields · synced Jul 23, 2026
- FDA UDI 515089d6-08f5-4bf8-b79f-1df3f9f806d2 34 fields · synced May 30, 2026