← Back to catalogue
OAE EarTips
EUDAMEDClass I (EU MDR)
Ref 203201Model OAE EAR TIPRef 203202Ref 203209Ref 203208Ref 203210Ref 203219Ref 203218
Identity
- Trade Name
- OAE EarTips EUDAMED
- Device Name
- OAE Jumbo Foam Tip (100) EUDAMED
- Model / Reference
- OAE EAR TIP EUDAMED203201 EUDAMED203202 EUDAMED203209 EUDAMED203208 EUDAMED203210 EUDAMED203219 EUDAMED203218 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05713315012075 EUDAMED05713315012082 EUDAMED05713315012105 EUDAMED05713315012099 EUDAMED05713315012112 EUDAMED05713315012150 EUDAMED05713315012143 EUDAMED
- Basic UDI-DI
- 5713315NA001104Y EUDAMED
- Direct Marketing DI
- 05713315012075 EUDAMED05713315012082 EUDAMED05713315012105 EUDAMED05713315012099 EUDAMED05713315012150 EUDAMED05713315012143 EUDAMED
- EMDN Code
- Z129013 GENERAL AUDITORY AND/OR VISUAL STIMULATORS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Denmark 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
OAE EarTips by Natus Medical Denmark ApS — 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 | 5713315NA001104Y | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Natus Medical Denmark ApS
- EUDAMED SRN
- DK-MF-000001617
Sources (7)
- EUDAMED 13fa78a8-b8ec-41c4-b520-38c9bbc4247f 61 fields · synced Aug 3, 2026
- EUDAMED 52dd78cb-d5d9-4ed5-a4c1-4e4eca325cc4 61 fields · synced May 17, 2026
- EUDAMED a7e45b8b-3908-43f8-b461-19f2a2e398d7 61 fields · synced May 17, 2026
- EUDAMED f96e4e7f-7bc7-418f-9a0c-b25306e169e7 61 fields · synced May 18, 2026
- EUDAMED 5dbb5d47-480f-488d-974c-26d30a0800ee 61 fields · synced May 18, 2026
- EUDAMED a27646f3-cff3-4687-8eba-f20787bfb213 61 fields · synced May 18, 2026
- EUDAMED 06406a07-38c0-4fe2-9acd-8bb89d66ed15 61 fields · synced May 18, 2026