Identity
- Trade Name
- Patient Monitor EUDAMEDRespArray FDA UDI
- Generic Name
- General-purpose multi-parameter bedside monitor FDA UDI
- Device Name
- Patient Monitor EUDAMED
- Model / Reference
- RespArray EUDAMED83.60.262411 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06944413821316 EUDAMEDFDA UDI
- Basic UDI-DI
- 69444138RespArrayTA EUDAMED
- 510(k) Number
- K220308 FDA UDI
- FDA Product Code
- MHX FDA UDIDRT FDA UDIDXN FDA UDIDSK FDA UDIFLL FDA UDIDQA FDA UDICCK FDA UDIDSI FDA UDIMLD FDA UDIDSB FDA UDI
- EMDN Code
- Z1203020201 MULTI–PARAMETER PATIENT BEDSIDE MONITORS EUDAMED
- GMDN Term
- General-purpose multi-parameter bedside monitor FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 870.1025 FDA UDI870.2300 FDA UDI870.1130 FDA UDI870.1110 FDA UDI880.2910 FDA UDI870.2700 FDA UDI868.1400 FDA UDI870.2770 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
Yes
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
MR Unsafe FDA UDI
Patient Monitor 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
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 | K220308 | Class IIb | Active |
| FDA 510(k) | United States | FDA_510K | K240320 | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 69444138RespArrayTA | 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 cc979787-cf39-46f9-9451-ea73b9a85057 61 fields · synced Jul 15, 2026
- FDA UDI acb903c2-eb03-420b-8eb3-9bc474675932 33 fields · synced May 30, 2026
- FDA 510(k) K220308 1 fields · synced May 18, 2026