← Back to catalogue
Patient Monitor
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref NeptuneRef M80Ref M8ARef iV15Ref M50Ref iX15Ref UX12Ref iV17Ref X12Ref elite V8Ref CX15Ref iM8Ref iX12Ref iM8ARef X10Ref UX10Ref M8BRef M8Ref iM20Ref iM80
Identity
- Trade Name
- Patient Monitor EUDAMEDFDA UDI
- Generic Name
- General-purpose multi-parameter bedside monitor FDA UDI
- Device Name
- Patient Monitor EUDAMED
- Model / Reference
- Neptune EUDAMEDX12 EUDAMEDFDA UDIM80 EUDAMEDFDA UDIiX15 EUDAMEDFDA UDIiX12 EUDAMEDFDA UDIX10 EUDAMEDFDA UDIUX12 EUDAMEDFDA UDIUX10 EUDAMEDFDA UDIiM8 EUDAMEDFDA UDIelite V8 EUDAMEDFDA UDIiM20 EUDAMEDFDA UDIM50 EUDAMEDFDA UDIiM80 EUDAMEDFDA UDICX15 EUDAMEDFDA UDIiM8A EUDAMEDFDA UDIM8A EUDAMEDiV15 EUDAMEDiV17 EUDAMEDM8B EUDAMEDM8 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06944413835344 EUDAMED06944413810945 EUDAMEDFDA UDI06944413800816 EUDAMEDFDA UDI06944413815902 EUDAMEDFDA UDI06944413815896 EUDAMEDFDA UDI06944413810921 EUDAMEDFDA UDI06944413838444 EUDAMEDFDA UDI06944413838437 EUDAMEDFDA UDI06944413801592 EUDAMEDFDA UDI06944413801707 EUDAMEDFDA UDI06944413802179 EUDAMEDFDA UDI06944413800823 EUDAMEDFDA UDI06944413801646 EUDAMEDFDA UDI06944413838420 EUDAMEDFDA UDI06944413801608 EUDAMEDFDA UDI06944413800045 EUDAMED06944413827608 EUDAMED06944413834415 EUDAMED06944413800540 EUDAMED06944413800038 EUDAMED
- Basic UDI-DI
- 69444138Neptune8E EUDAMED69444138iMS8K EUDAMED69444138iM8SZS EUDAMED69444138iV12SZ4 EUDAMED69444138iXS9L EUDAMED69444138CXS4F EUDAMED69444138XSGP EUDAMED69444138VSGH EUDAMED69444138iM20X4 EUDAMED
- 510(k) Number
- K250179 FDA UDI
- FDA Product Code
- DQA FDA UDIMHX FDA UDIDRT FDA UDIDXN FDA UDIMLD FDA UDIFLL FDA UDIDSK FDA UDIDSB FDA UDICCK FDA UDIDSI FDA UDICBQ FDA UDICBR FDA UDICBS FDA UDICCL FDA UDINHP FDA UDIBZQ FDA UDIDPS FDA UDINHO FDA UDINHQ FDA UDIDSA FDA UDIDSF FDA UDIBZK FDA UDIDRG 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
- 870.2700 FDA UDI870.1025 FDA UDI870.2300 FDA UDI870.1130 FDA UDI880.2910 FDA UDI870.1110 FDA UDI870.2770 FDA UDI868.1400 FDA UDI868.1500 FDA UDI868.1700 FDA UDI868.1620 FDA UDI868.1720 FDA UDI868.2375 FDA UDI870.2340 FDA UDI870.2900 FDA UDI870.2810 FDA UDI868.1850 FDA UDI870.2910 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
MR Unsafe FDA UDI
Patient Monitor by Edan Instruments, Inc. — Class IIb — 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 | 69444138Neptune8E | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Edan Instruments, Inc.
- EUDAMED SRN
- CN-MF-000009957
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (34)
- EUDAMED 1ed87eec-9b6d-4a6c-af06-ccadffcb2230 61 fields · synced Aug 2, 2026
- FDA UDI 9beb6591-23e6-44d7-ae3b-bf16a8216de9 32 fields · synced May 29, 2026
- FDA UDI 9f6138c3-63a9-4a7a-94c3-16b4260c8fea 32 fields · synced May 30, 2026
- FDA UDI 92e29afc-71f6-4974-b335-541d4af50c41 32 fields · synced May 30, 2026
- FDA UDI 7920c633-bc47-44a0-8d25-0cb38c65ad51 32 fields · synced May 30, 2026
- FDA UDI cb4920d6-effa-46f8-aed1-9c75ecba6360 32 fields · synced May 30, 2026
- FDA UDI 9477b3b1-e0cb-418b-9a8e-40af2caad1c3 33 fields · synced May 30, 2026
- FDA UDI 92f4585e-7972-44d1-add8-aef3e0ab2201 33 fields · synced May 30, 2026
- FDA UDI f92170bc-ddee-4cee-9e57-07f68510b65f 32 fields · synced May 30, 2026
- FDA UDI 74d08a59-ac2f-49f0-816d-254484326294 32 fields · synced May 30, 2026
- FDA UDI e56ee980-5e7d-4c51-a9b0-4ca3697b03de 32 fields · synced May 30, 2026
- FDA UDI 38b2100f-10ca-4958-b846-710a27fe9046 32 fields · synced May 30, 2026
- FDA UDI 7fa4e38d-fdb2-47b2-bdd6-f95b9b4bfe63 32 fields · synced May 30, 2026
- FDA UDI ad100cbd-bf2f-4fdf-b77d-12223a20f5e4 33 fields · synced May 30, 2026
- FDA UDI decaca43-4c5a-4bcf-aaea-249ee6abca7d 32 fields · synced May 30, 2026
- EUDAMED e20bbd3e-95cc-49ab-87d7-7fefe46d753f 61 fields · synced Jun 20, 2026
- EUDAMED 1da577a3-328f-4c42-9220-63f459c7a3b8 61 fields · synced Jul 9, 2026
- EUDAMED 2c64fb3b-9ccd-4077-9048-1fb48f709bd9 61 fields · synced Jul 9, 2026
- EUDAMED 8f2138ed-d943-427b-b130-b35953f1a698 61 fields · synced Jul 9, 2026
- EUDAMED ac34faa7-1d9c-4a29-906a-5f03c043a202 61 fields · synced Jul 10, 2026
- EUDAMED 68d4cbcf-ae58-4274-841d-5bddc30ee436 61 fields · synced Jul 12, 2026
- EUDAMED 06f17c2a-3bc5-4292-b22d-baac0801874e 61 fields · synced Jul 12, 2026
- EUDAMED 03df55ca-ebf0-4298-9209-05df0979ea34 61 fields · synced Jul 14, 2026
- EUDAMED 91b4c489-a69a-4c9c-9b25-a55942742018 61 fields · synced Jul 14, 2026
- EUDAMED b9f328ab-bd16-4bd7-9ce2-ef93d7b4677e 61 fields · synced Jul 16, 2026
- EUDAMED 18b1606b-2d01-4946-96ef-b16fef9c586c 61 fields · synced Jul 17, 2026
- EUDAMED 2e468059-4ef3-4b00-91af-bfd0992df3a7 61 fields · synced Jul 17, 2026
- EUDAMED e0b7c5b3-3b39-458c-a84c-b195bdb803ec 61 fields · synced Jul 19, 2026
- EUDAMED b3376b2a-ff0a-46aa-ae7b-aa0628531bb8 61 fields · synced Jul 22, 2026
- EUDAMED 10f52c5e-dd54-4ce2-96a5-47e0bec7ce19 61 fields · synced Jul 23, 2026
- EUDAMED a6314665-c4ef-4445-aedd-c821049a4815 61 fields · synced Jul 25, 2026
- EUDAMED 1a491d7e-8390-4e9d-a062-8aedbbc9e00a 61 fields · synced Jul 25, 2026
- EUDAMED 7be054d1-ab41-4b92-b3bb-161b699feda4 61 fields · synced Aug 2, 2026
- EUDAMED 25dbb6af-e9c6-4c55-b7ae-4133e15b7eae 61 fields · synced Aug 2, 2026