← Back to catalogue
Flexible Irrigation Needles
EUDAMEDFDA UDIClass I (EU MDR)
Ref FYCX0019Model DTO-FLEX
Identity
- Trade Name
- CICADA FDA UDI
- Generic Name
- Dental syringe needle, single-use FDA UDI
- Device Name
- Flexible Irrigation Needles EUDAMEDDisposable/Dental lrrigation Needle FDA UDI
- Model / Reference
- DTO-FLEX EUDAMEDFYCX0019 EUDAMEDS-30G-26 FDA UDI
- Description
- Disposable/Dental lrrigation Needle FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06974456210051 EUDAMEDFDA UDI
- Basic UDI-DI
- 697445621DTO-FLEX8N EUDAMED
- FDA Product Code
- DZM FDA UDI
- EMDN Code
- A010602 DENTAL IRRIGATION NEEDLES EUDAMED
- GMDN Term
- Dental syringe needle, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.4730 FDA UDI
- Market of Registration
- France 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
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Flexible Irrigation Needles by Foshan CICADA Dental Instrument Co., Ltd. — 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 | 697445621DTO-FLEX8N | 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
- Foshan Cicada Dental Instrument Co., Ltd
- EUDAMED SRN
- CN-MF-000001167
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (2)
- EUDAMED 7a50cf80-26be-4229-93cf-8dfe5e4ab8b4 61 fields · synced Jul 23, 2026
- FDA UDI 074c5b98-a66f-4ad0-8ebf-de4169b3536d 33 fields · synced May 30, 2026