Identity
- Trade Name
- REM Test tubes, 1.1mm (50 pcs.) EUDAMEDGN Otometrics A/S FDA UDI
- Generic Name
- Hearing aid tester, electrical FDA UDI
- Device Name
- REM Test tubes, 1.1mm (50 pcs.) EUDAMED
- Model / Reference
- 8-62-35100 EUDAMEDREM Test tubes, 1.1mm (50 pcs.) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05713315003301 EUDAMEDFDA UDI
- Basic UDI-DI
- 5713315NA000885Y EUDAMED
- FDA Product Code
- ETW FDA UDI
- EMDN Code
- Y214599 HEARING AIDS - OTHER EUDAMED
- GMDN Term
- Hearing aid tester, electrical FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 874.3310 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
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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
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
Yes
FDA UDI
REM Test tubes, 1.1mm (50 pcs.) by Natus Medical Denmark ApS — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 5713315NA000885Y | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Natus Medical Denmark ApS
- EUDAMED SRN
- DK-MF-000001617
Sources (2)
- EUDAMED de87ded9-a110-4dd6-994d-32d22f1aa18e 61 fields · synced Jul 9, 2026
- FDA UDI 7fe54968-5cb4-47dd-a096-2be3f9c3a634 32 fields · synced May 30, 2026