Identity
- Trade Name
- Telemetry Transmitter EUDAMEDFDA UDI
- Generic Name
- General-purpose multi-parameter bedside monitor FDA UDI
- Device Name
- Telemetry Transmitter EUDAMED
- Model / Reference
- iT20 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06944413802261 EUDAMEDFDA UDI
- Basic UDI-DI
- 69444138iT20Y7 EUDAMED
- 510(k) Number
- K161056 FDA UDI
- FDA Product Code
- DRG FDA UDIDPS FDA UDIGXY FDA UDIBZQ FDA UDIDRT FDA UDIMLD FDA UDIDSI FDA UDIMHX FDA UDIDQA FDA UDI
- EMDN Code
- Z1203020603 VITAL SIGNS TELEMETRY TRANSMITTER EUDAMED
- GMDN Term
- General-purpose multi-parameter bedside monitor FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 870.2910 FDA UDI870.2340 FDA UDI882.1320 FDA UDI868.2375 FDA UDI870.2300 FDA UDI870.1025 FDA UDI870.2700 FDA UDI
- Market of Registration
- Germany 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
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
Telemetry Transmitter by Edan Instruments, Inc. — Class IIb — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K161056 | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 69444138iT20Y7 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Edan Instruments, Inc.
- EUDAMED SRN
- CN-MF-000009957
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (3)
- EUDAMED 450e7835-31f0-4921-9dbb-a4c2f188d17f 61 fields · synced Jun 19, 2026
- FDA UDI 86ff7801-64ce-4133-8e40-d6926a072a2e 33 fields · synced May 30, 2026
- FDA 510(k) K161056 1 fields · synced May 18, 2026