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Fitting, 0.25 BSP Spiral, i3
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref PIL0322
by Zyris, Inc.
Identity
- Trade Name
- Isolite, i3 FDA UDI
- Generic Name
- Dental suction system FDA UDI
- Device Name
- Fitting, 0.25 BSP Spiral, i3 EUDAMED0.25 BSP Spiral Fitting FDA UDI
- Model / Reference
- PIL0322 EUDAMEDFDA UDI
- Description
- 0.25 BSP Spiral Fitting FDA UDI
Identifiers
- Catalog Number
- PIL0322 FDA UDI
- Primary DI / UDI-DI
- 00810032660949 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00810032660949 EUDAMED
- FDA Product Code
- EBR FDA UDI
- EMDN Code
- Q019001 SALIVA ASPIRATORS AND SALIVA ABSORBENTS EUDAMED
- GMDN Term
- Dental suction system FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.6640 FDA UDI
- Market of Registration
- Germany 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Fitting, 0.25 BSP Spiral, i3 by Zyris, Inc. — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00810032660949 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Zyris, Inc.
- EUDAMED SRN
- US-MF-000034843
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED e134106c-8dbb-47d0-bda3-d3c82ff883ea 61 fields · synced Jun 18, 2026
- FDA UDI 554b29e7-ec10-44a2-8620-95b8bcb587e6 35 fields · synced May 29, 2026