Identity
- Device Name
- Occlude Disposable Tips EUDAMED
- Model / Reference
- 05400 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00310866000244 EUDAMED
- Basic UDI-DI
- 031086611001Z3 EUDAMED
- EMDN Code
- Q01020202 SPRAY AND LIQUID DENTAL CONTACT INDICATORS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands 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
Occlude Disposable Tips by Pascal Company, Inc. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 031086611001Z3 | Class I | Active |
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Manufacturer
- Manufacturer
- Pascal Company Inc.
- EUDAMED SRN
- US-MF-000032036
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED f02bd8ab-fa45-4c7c-9c44-c6fee8f82ea8 61 fields · synced Jul 28, 2026