Identity
- Trade Name
- ORL-Set EUDAMED
- Device Name
- CombiSet ENTsurgery EUDAMED
- Model / Reference
- 3152 EUDAMED2337333 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04099467179998 EUDAMED
- Basic UDI-DI
- 40495003152KD EUDAMED
- EMDN Code
- V0599 CLINICAL PROCEDURES KITS NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Medical Purpose
- A CombiSet is characterized by the customized compilation of defined components used for medical treatments. These are single-use products for surgical procedures. EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Category: Ophthalmic surgical procedure kit, non-medicated, single-use
ORL-Set by Paul Hartmann Ag — Class III — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Ophthalmic surgical procedure kit, non-medicated, 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 | 40495003152KD | Class III | Active |
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Manufacturer
- Manufacturer
- Paul Hartmann Ag
- EUDAMED SRN
- DE-PR-000019925
Sources (1)
- EUDAMED 26022809-1a98-41f5-8865-991b53494246 61 fields · synced Jun 19, 2026