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Smartsigns
EUDAMEDClass IIb (EU MDR)
Ref SC1500 5NIModel SC300Ref SC1500 12NPRef SC1200 5NPRef SC500 HPRef SC1200 5HIRef SC1200 5HIPRef SC500 NERef SC500 HRef SC1500 5HRef SC1500 12NIPRef SC1200 12NIPRef SC500 NRef SC1500 5HIPRef SC500 NTERef SC300NTRef SC500 NTRef SC1500 5HPRef SC500 HTERef SC500 NTPRef SC1200 12HPRef SC500 NEPRef SC500 HTPRef CV-SYSTEMRef SC300NRef CV-SOFTWARERef ACC-VSM-213Ref ACC-VSM-214Ref SC1200 5NIRef SC500 NTEPRef SC1200 12HIRef SC1200 5H
Identity
- Trade Name
- SMARTSIGNS EUDAMED
- Device Name
- SC300 SPOT MONITOR EUDAMED3 WAY IEC PATIENT CABLE EUDAMED
- Model / Reference
- SC300 EUDAMEDSC1500 5NI EUDAMEDSC1500 12NP EUDAMEDSC1200 5NP EUDAMEDSC500 HP EUDAMEDSC1200 5HI EUDAMEDSC1200 5HIP EUDAMEDSC500 NE EUDAMEDSC500 H EUDAMEDSC1500 5H EUDAMEDSC1500 12NIP EUDAMEDSC1200 12NIP EUDAMEDSC500 N EUDAMEDSC1500 5HIP EUDAMEDSC500 NTE EUDAMEDSC300NT EUDAMEDSC500 NT EUDAMEDSC1500 5HP EUDAMEDSC500 HTE EUDAMEDSC500 NTP EUDAMEDSC1200 12HP EUDAMEDSC500 NEP EUDAMEDSC500 HTP EUDAMEDCV-SYSTEM EUDAMEDSC300N EUDAMEDCV-SOFTWARE EUDAMEDACC-VSM-213 EUDAMEDACC-VSM-214 EUDAMEDSC1200 5NI EUDAMEDSC500 NTEP EUDAMEDSC1200 12HI EUDAMEDSC1200 5H EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05051968040862 EUDAMED05051968040916 EUDAMED05051968040244 EUDAMED05051968043542 EUDAMED05051968040213 EUDAMED05051968040299 EUDAMED05051968043566 EUDAMED05051968043511 EUDAMED05051968040800 EUDAMED05051968040954 EUDAMED05051968040329 EUDAMED05051968043528 EUDAMED05051968040923 EUDAMED05051968043634 EUDAMED05051968033239 EUDAMED05051968043580 EUDAMED05051968040855 EUDAMED05051968043603 EUDAMED05051968043641 EUDAMED05051968040268 EUDAMED05051968043627 EUDAMED05051968043610 EUDAMED05051968041166 EUDAMED05051968033222 EUDAMED05051968041203 EUDAMED05051968030092 EUDAMED05051968030108 EUDAMED05051968040237 EUDAMED05051968043665 EUDAMED05051968040251 EUDAMED05051968040176 EUDAMED
- Basic UDI-DI
- 5060693520372WF EUDAMED5060693520464WM EUDAMED
- EMDN Code
- Z1203020280 MULTI-PARAMETER MONITORS - HARDWARE ACCESSORIES EUDAMEDZ1203020282 MULTI-PARAMETER MONITORS - SOFTWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class IIb EUDAMEDClass I EUDAMED
- Market of Registration
- Ireland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
EUDAMEDEUDAMED
Incorporates Medicinal Product
No
EUDAMED
Smartsigns by Arjohuntleigh AB — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 5060693520372WF | Class IIb | Active |
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Manufacturer
- Manufacturer
- ArjoHuntleigh AB
- EUDAMED SRN
- SE-MF-000000696
Sources (31)
- EUDAMED 93644be2-8ad8-4fdd-a682-8dd6b006dd3d 61 fields · synced Sep 18, 2026
- EUDAMED 9caa5850-b265-4ce0-908d-4dca06d57886 61 fields · synced May 16, 2026
- EUDAMED 28c26278-db7d-4dca-95b1-ffcf2701a116 61 fields · synced May 16, 2026
- EUDAMED b179b7c3-3ebf-4f45-8f45-d530de95a7ab 61 fields · synced May 16, 2026
- EUDAMED 2002dc83-782d-4826-a890-de30a73c3a68 61 fields · synced May 16, 2026
- EUDAMED a42ed800-43f8-4cd1-8e50-8cf526b6bc2b 61 fields · synced May 17, 2026
- EUDAMED baee4e69-3a13-47b9-9771-b11141e5d96c 61 fields · synced May 17, 2026
- EUDAMED e2db6b7d-51ad-486c-90e4-ed6f91edb1c5 61 fields · synced May 17, 2026
- EUDAMED f1dde90a-aca4-4a41-93f2-a4907f091ee1 61 fields · synced May 17, 2026
- EUDAMED c0da4c57-5638-4e0f-a080-a290ecc96425 61 fields · synced May 17, 2026
- EUDAMED 327ff44a-b07f-4d39-b848-d9da6ad53053 61 fields · synced May 17, 2026
- EUDAMED 3f5a4c8e-10f6-46d0-a654-e8c1e9364822 61 fields · synced May 17, 2026
- EUDAMED a55114a8-7c83-4887-9a7e-554c3076f312 61 fields · synced May 17, 2026
- EUDAMED e20405a9-a73c-47ef-98e5-eb7fb77f303d 61 fields · synced May 17, 2026
- EUDAMED c72ffddc-956c-43b7-be29-31f10c13a395 61 fields · synced May 17, 2026
- EUDAMED 41212017-6249-4502-9403-9f7e07088be5 61 fields · synced May 17, 2026
- EUDAMED ca2c98f0-f07b-41b6-ad23-e1495bbc0004 61 fields · synced May 17, 2026
- EUDAMED 313fe38d-2192-4d9b-8f6d-51c9b1e156a8 61 fields · synced May 17, 2026
- EUDAMED 147b04b6-573c-4aa7-b7c3-43dccc481f5e 61 fields · synced May 17, 2026
- EUDAMED c50b0c6c-5e6f-4927-a6b8-8656a634a905 61 fields · synced May 18, 2026
- EUDAMED e5108899-38e5-45b3-94c4-2ac5b1b0661c 61 fields · synced May 18, 2026
- EUDAMED 31ce9a61-b7c7-471c-8e08-bbcef19f781f 61 fields · synced May 18, 2026
- EUDAMED 5c8d6cbb-2e2c-48df-bbbd-ef65d19b3c0f 61 fields · synced May 18, 2026
- EUDAMED 75de7842-df53-479e-836f-f312ffe2b0a4 61 fields · synced May 18, 2026
- EUDAMED f89c454b-dc91-4482-9f14-e8c9816983fe 61 fields · synced May 18, 2026
- EUDAMED 9d1fc728-6a11-4753-8407-6ed42b01a815 61 fields · synced May 18, 2026
- EUDAMED 6f5f6272-6a61-4add-b2b2-8aa9d02a283c 61 fields · synced May 18, 2026
- EUDAMED f34a2d93-d923-4260-980c-c74d8befbb74 61 fields · synced May 18, 2026
- EUDAMED 4f2b7917-81a2-46a9-901e-68b5af67c123 61 fields · synced May 19, 2026
- EUDAMED 54a77013-223a-47c7-be0d-c2827d6cb4f8 61 fields · synced May 19, 2026
- EUDAMED 9df0ed07-7d36-419c-ac02-acb2be4c0c7e 61 fields · synced May 19, 2026