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Posterior Mouthpiece
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref CIL0701Model Mouthpiece, 10-Pack, Medium
by Zyris, Inc.
Identity
- Trade Name
- Posterior Mouthpiece EUDAMEDIsolite Moutpiece FDA UDI
- Generic Name
- Hand-held dental retractor FDA UDI
- Device Name
- Mouthpiece, 10-Pack, Medium FDA UDI
- Model / Reference
- Mouthpiece, 10-Pack, Medium EUDAMEDCIL0701 EUDAMEDFDA UDI
- Description
- Mouthpiece, 10-Pack, Medium FDA UDI
Identifiers
- Catalog Number
- CIL0701 FDA UDI
- Primary DI / UDI-DI
- 00810032660147 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00810032660147 EUDAMED
- FDA Product Code
- DYN FDA UDIEIF FDA UDI
- EMDN Code
- Q019001 SALIVA ASPIRATORS AND SALIVA ABSORBENTS EUDAMED
- GMDN Term
- Hand-held dental retractor FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.6640 FDA UDI872.4565 FDA UDI
- Market of Registration
- Germany 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
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
Yes
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
Moist Heat or Steam Sterilization FDA UDI
Posterior Mouthpiece 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-00810032660147 | 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 500510ed-a4f8-4f9e-bb87-14b6fd63f475 61 fields · synced Jun 19, 2026
- FDA UDI f46e0fe3-0720-4c9e-b905-47b12ec653e5 36 fields · synced May 29, 2026