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Posterior Mouthpiece
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref CIL0601Model Mouthpiece, 10-Pack, Small
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, Small FDA UDI
- Model / Reference
- Mouthpiece, 10-Pack, Small EUDAMEDCIL0601 EUDAMEDFDA UDI
- Description
- Mouthpiece, 10-Pack, Small FDA UDI
Identifiers
- Catalog Number
- CIL0601 FDA UDI
- Primary DI / UDI-DI
- 00810032660116 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00810032660116 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-00810032660116 | 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 b3aa7e5b-17eb-437d-b231-039538195ed5 61 fields · synced Jun 18, 2026
- FDA UDI 7ae352b8-446b-4c37-b15e-a2fbe1b969ab 36 fields · synced May 30, 2026