Identity
- Trade Name
- NA FDA UDI
- Generic Name
- Auditory stimulator FDA UDI
- Device Name
- Ear Tips for AEP Earphone EUDAMED
- Model / Reference
- 8001233 EUDAMEDEar tips for earphone, 8001233 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840682103473 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00840682103473 EUDAMED
- 510(k) Number
- K051883 FDA UDI
- FDA Product Code
- GWJ FDA UDIORT FDA UDIOLT FDA UDIMHX FDA UDIOMC FDA UDIMLD FDA UDI
- EMDN Code
- Z1203020285 MULTI-PARAMETER MONITORS - CONSUMABLES EUDAMED
- GMDN Term
- Auditory stimulator FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 882.1900 FDA UDI882.1400 FDA UDI870.1025 FDA UDI
- Market of Registration
- Finland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Category: General-purpose multi-parameter bedside monitor
Ear Tips for AEP Earphone by GE Healthcare Finland Oy — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00840682103473 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- GE Healthcare Finland Oy
- EUDAMED SRN
- FI-MF-000001176
Sources (2)
- EUDAMED fe1eaf71-8dae-4c95-81a4-5ee80129d262 61 fields · synced Oct 6, 2026
- FDA UDI e4b2fb8d-100c-4b35-9a12-853fbbfde3b1 34 fields · synced May 30, 2026