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Mr. Thirsty® One-Step Large (with Ø10mm Adaptor)
EUDAMEDClass IIa (EU MDR)
Ref 50Z989LG10Ref 50Z989LG-B10
Identity
- Trade Name
- Mr. Thirsty® One-Step Large (with Ø10mm Adaptor) EUDAMED
- Device Name
- Mr. Thirsty® One-Step - High Volume Evacuator - Large (with 10mm Adaptors) - 50 Count EUDAMEDMr. Thirsty® One-Step - High Volume Evacuator - Large (with 10mm Adaptors) - 100 Count EUDAMED
- Model / Reference
- 50Z989LG10 EUDAMED50Z989LG-B10 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 40840161307116 EUDAMED50840161307113 EUDAMED
- Basic UDI-DI
- B-40840161307116 EUDAMEDB-50840161307113 EUDAMED
- EMDN Code
- Q019001 SALIVA ASPIRATORS AND SALIVA ABSORBENTS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Mr. Thirsty® One-Step Large (with Ø10mm Adaptor) by Zirc Dental Products, Inc. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-40840161307116 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Zirc Dental Products Inc.
- EUDAMED SRN
- US-MF-000021065
- Authorised Representative
- Medicom GmbH DE-AR-000005612
Sources (2)
- EUDAMED 2422dbde-eb25-438b-b524-66be4f968388 61 fields · synced Aug 1, 2026
- EUDAMED 2bf95671-b339-4f67-bb87-00cbb66b6f15 61 fields · synced May 17, 2026