Identity
- Trade Name
- HYGIENE START UP KIT OPTIME SIZE 2 EUDAMED
- Device Name
- Protective bags EUDAMED
- Model / Reference
- 203685 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06430035873531 EUDAMED
- Basic UDI-DI
- 643003587HygieneSheath4N EUDAMED
- EMDN Code
- Z11030485 INSTRUMENTS FOR DIGITAL ENDORAL RADIOLOGY - CONSUMABLES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Finland 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
Hygiene Start Up Kit Optime Size 2 by PaloDEx Group Oy — 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 | 643003587HygieneSheath4N | Class I | Active |
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Manufacturer
- Manufacturer
- PaloDEx Group Oy
- EUDAMED SRN
- FI-MF-000004943
Sources (1)
- EUDAMED d40aae46-c00e-4c28-b652-5cd5156ec90c 61 fields · synced Jun 19, 2026