Identity
- Trade Name
- MADSEN Capella2 EUDAMEDMADSEN Capella2 DP+TE FDA UDI
- Generic Name
- Otoacoustic emission system, line-powered FDA UDI
- Device Name
- MADSEN Capella2 EUDAMED
- Model / Reference
- M011130 EUDAMED8-04-15320 EUDAMEDM016000C FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00817020029924 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00817020029924 EUDAMED
- 510(k) Number
- K061443 FDA UDI
- FDA Product Code
- EWO FDA UDI
- EMDN Code
- Z12149001 OTOACOUSTIC EMISSIONS EQUIPMENT EUDAMED
- GMDN Term
- Otoacoustic emission system, line-powered FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 874.1050 FDA UDI
- Market of Registration
- Denmark EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
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
Yes
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MADSEN Capella2 by Intelligent Hearing Systems Corp. — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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-00817020029924 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Intelligent Hearing Systems Corp.
- EUDAMED SRN
- US-MF-000011473
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 0cabddf7-3355-4517-ab68-d5a78ef9bd0d 61 fields · synced Jul 10, 2026
- FDA UDI a2b189c8-4c93-4581-93de-c6bf766aae19 33 fields · synced May 29, 2026