Identity
- Trade Name
- Parkell® EUDAMED
- Device Name
- Mixing Tip 5 EUDAMED
- Model / Reference
- S535 EUDAMEDS540 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 10810000528292 EUDAMED
- Basic UDI-DI
- 081000052MIXINGTIP5K5 EUDAMED
- Unit of Use DI
- 00810000528295 EUDAMED
- EMDN Code
- Q019006 DENTAL MATERIAL APPLICATION TIPS AND BRUSHES, SINGLE-USE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Parkell® by Parkell, 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 | 081000052MIXINGTIP5K5 | Class I | Active |
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Manufacturer
- Manufacturer
- Parkell Inc.
- EUDAMED SRN
- US-MF-000003761
- Authorised Representative
- Directa AB SE-AR-000002492
Sources (1)
- EUDAMED 318cdd5b-5873-41a3-aaa5-838b337407aa 61 fields · synced May 23, 2026