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Orbis
EUDAMEDClass I (EU MDR)
Ref PLANDENT400F-PRef 312424Ref 312418Ref 312416Ref 312419
Identity
- Trade Name
- ORBIS EUDAMED
- Device Name
- MICRO APPLICATORS EUDAMEDPATIENT TOWELS EUDAMED
- Model / Reference
- PLANDENT400F-P EUDAMED312424 EUDAMED312418 EUDAMED312416 EUDAMED312419 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04250476618087 EUDAMED04250476600198 EUDAMED04250476600181 EUDAMED04250476600167 EUDAMED04250476600105 EUDAMED
- Basic UDI-DI
- 42504766MICUL EUDAMED42504766PATVD EUDAMED
- EMDN Code
- Q019006 DENTAL MATERIAL APPLICATION TIPS AND BRUSHES, SINGLE-USE EUDAMEDT0306 PATIENT PROTECTION DEVICES DURING CLINICAL PROCEDURES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Finland EUDAMEDGermany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Category: Dental material injection cannula, single-use
Orbis by Akzenta International SA — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Dental material injection cannula, single-use.
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 42504766MICUL | Class I | Active |
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Manufacturer
- Manufacturer
- Akzenta International SA
- EUDAMED SRN
- CH-MF-000036434
- Authorised Representative
- IQX GmbH AT-AR-000016713
Sources (5)
- EUDAMED c70a43c6-39f9-4e77-8170-42141994df1e 61 fields · synced Jul 31, 2026
- EUDAMED 6d8837a9-d3b3-4d56-988b-ec233c8cc5a0 61 fields · synced Jul 13, 2026
- EUDAMED 1e233fa4-0513-4f15-ab88-2383863c84fc 61 fields · synced Jul 20, 2026
- EUDAMED aff0bd42-425b-4432-b133-b6555c27e062 61 fields · synced Jul 30, 2026
- EUDAMED 5c6d794c-9198-440c-9a1e-73f66f7d0332 61 fields · synced Jul 31, 2026