Identity
- Trade Name
- Protektor32 Pods and Pod Kit EUDAMED
- Device Name
- P32 ACQ Pod combine kit EUDAMED
- Model / Reference
- 002499 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00382830020879 EUDAMED
- Basic UDI-DI
- 038283NA00095EQ EUDAMED
- Direct Marketing DI
- 00382830020879 EUDAMED
- EMDN Code
- Z129013 GENERAL AUDITORY AND/OR VISUAL STIMULATORS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Ireland 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
Protektor32 Pods and Pod Kit by Natus Medical Incorporated Dba Excel-Tech Ltd (xltek) — 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 | 038283NA00095EQ | Class I | Active |
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Manufacturer
- EUDAMED SRN
- CA-MF-000004001
- Authorised Representative
- Natus Manufacturing Ltd IE-AR-000000884
Sources (1)
- EUDAMED 6cb398d9-6807-40c4-bf28-39b2c5d7429f 61 fields · synced Jun 19, 2026