OAE EarTips
by Natus Medical Denmark ApS 3 variants
Ref 203211Model OAE EAR TIP
OAE EarTips (203211) is a Class I device made by Natus Medical Denmark ApS, registered in EUDAMED on 30 Apr 2026 (Basic UDI-DI 5713315NA001104Y) and listed in FDA GUDID since 22 Dec 2025 (UDI-DI 05713315012129), active as of 22 Oct 2026.
Active
CE MDR
Valid until
No date given
FDA recalls
Not checked
Documents
None, self-declared
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number5713315NA001104Y 05713315012129 | Date30 Apr 2026 | StatusActive |
| United States | GUDID listing GUDID | Number05713315012129 | Date22 Dec 2025 | StatusListed |
Official records
- EUDAMED public site 5713315NA001104Y
- AccessGUDID record 05713315012129
Across registries
- EUDAMED Basic UDI-DI 5713315NA001104Y registered 30 Apr 2026 Active
- FDA GUDID UDI-DI 05713315012129 listed 22 Dec 2025 Listed
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Timeline
- Listed FDA GUDID 05713315012129
- Registered EUDAMED 5713315NA001104Y
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Generic name
- Audiometric ear tip
- Device name
- OAE Jumbo Foam Tip (100)
- Model / reference
- OAE EAR TIP, 203211
- Primary DI / UDI-DI
- 05713315012129
- Basic UDI-DI
- 5713315NA001104Y
- Direct marketing DI
- 05713315012129
- FDA product code
- ETT
- EMDN code
- Z129013 General auditory and/or visual stimulators
- GMDN term
- Audiometric ear tip
- Device class
- Class I
- Regulation number
- 874.1100
- System or procedure pack
- Procedure pack which is a device in itself
- EU registration type
- Standard device
- EU market of registration
- Denmark
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Unsafe
Manufacturer details
- EUDAMED SRN
- DK-MF-000001617
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