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Sterile Irrigation Systems M-M W&H/Nobel Biocare
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref HY-110001Model Irrigation System
by Hygitech
Identity
- Trade Name
- STERILE IRRIGATION SYSTEMS M-M W&H/NOBEL BIOCARE EUDAMEDHYGITECH FDA UDI
- Generic Name
- Oral lavage system FDA UDI
- Device Name
- HYGITECH offers a complete range of irrigation sets compatible with most implantology motors on the market. Irrigation is an essential element of an implant surgery and limits the heating of bone and adjacent tissues. FDA UDI
- Model / Reference
- Irrigation System EUDAMEDHY-110001 EUDAMEDFDA UDI
- Description
- HYGITECH offers a complete range of irrigation sets compatible with most implantology motors on the market. Irrigation is an essential element of an implant surgery and limits the heating of bone and adjacent tissues. FDA UDI
Identifiers
- Catalog Number
- HY-110001 FDA UDI
- Primary DI / UDI-DI
- 03615140001618 EUDAMEDFDA UDI
- Basic UDI-DI
- 361514H3IRRI171VW EUDAMED
- FDA Product Code
- EFS FDA UDI
- EMDN Code
- A03040299 IRRIGATION KITS, SINGLE-USE - OTHER EUDAMED
- GMDN Term
- Oral lavage system FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.6510 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Sterile Irrigation Systems M-M W&H/Nobel Biocare by Hygitech — Class IIa — 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 | 361514H3IRRI171VW | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Hygitech
- EUDAMED SRN
- FR-MF-000007549
Sources (2)
- EUDAMED 708de289-7648-41dd-a38c-77b5558e5046 61 fields · synced Oct 5, 2026
- FDA UDI 9edddb8b-20eb-4cbf-a6cc-ea5dd69a535f 34 fields · synced May 30, 2026