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Barco
EUDAMEDFDA UDIClass I (EU MDR)
Ref K9352401BModel Surgical DisplayRef K9307929BRef 991932204025Ref K9301100AModel Pathology DisplayRef K9352860Ref 991932204024Ref K930792502BRef K9300360C2XModel Radiology DisplayRef K9300372C1XRef K9307918BRef K9352422Ref K9352391Ref K9300390A2XRef K93530121XRef K9307931Ref K9352360Ref 600301482Model Nexxis ORRef K9353111Ref K9307939Ref K9352172Ref K9352290
by Barco NV
Identity
- Trade Name
- Barco EUDAMEDFDA UDINio Color 3MP FDA UDINio 5.8MP Gray FDA UDI
- Generic Name
- Image display unit, colour FDA UDIDigital pathology image display unit IVD FDA UDIRadiology picture archiving and communication system workstation FDA UDIOperating room audiovisual data/device management system FDA UDI
- Device Name
- MDSC-8255, MDSC-8232, MDSC-8232 M3D, MDSC-8358, MDSC-8331, AR 3250-3209, JMFS314KB, MDSC-8527, AR-3250-2701, MDSC-8532, AR-3250-3211, MDEC-2523, VividImage 32 4K EUDAMEDMDPC-8127 EUDAMEDFDA UDIMDNC-6121, MDNG-6221, MDNC-12130 EUDAMEDMDNC-2123, MDNC-3521, MDNC-3421 EUDAMEDMNA-120, MNA-240, MNA-420, MNA-440, NMS 1.18 EUDAMEDMDSC-8255 LED FDA UDIJFMS314KB FDA UDIMDSC-8358 MNA ABB FDA UDIMDSC-8532 NXF FDA UDIMDSC-8255 MNA FDA UDIMDFC-8232 3SW FDA UDIMDNC-3521 SPES FDA UDIMDNG-6221 SNEF FDA UDIMDSC-8358 RL FDA UDIVANTAGEVIEW 2.0 DECODER FDA UDIMDFC-8232 3HB FDA UDI
- Model / Reference
- Surgical Display EUDAMEDK9352401B EUDAMEDK9307929B EUDAMED991932204025 EUDAMEDPathology Display EUDAMEDK9301100A EUDAMEDK9352860 EUDAMED991932204024 EUDAMEDK930792502B EUDAMEDRadiology Display EUDAMEDK9300360C2X EUDAMEDK9300372C1X EUDAMEDK9307918B EUDAMEDK9352422 EUDAMEDK9352391 EUDAMEDK9300390A2X EUDAMEDK93530121X EUDAMEDK9307931 EUDAMEDK9352360 EUDAMEDNexxis OR EUDAMED600301482 EUDAMEDK9353111 EUDAMEDK9307939 EUDAMEDK9352172 EUDAMEDK9352290 EUDAMEDMDSC-8255 FDA UDIMDSC-8232 FDA UDIMDSC-8358 FDA UDIMDSC-8532 FDA UDIMDFC-8232 FDA UDIMDPC-8127 FDA UDIMDNC-3521 FDA UDIMDNG-6221 FDA UDIMNA-240 FDA UDI
- Description
- MDSC-8255 LED FDA UDIJFMS314KB FDA UDIMDSC-8358 MNA ABB FDA UDIMDSC-8532 NXF FDA UDIMDSC-8255 MNA FDA UDIMDFC-8232 3SW FDA UDIMDPC-8127 FDA UDIMDNC-3521 SPES FDA UDIMDNG-6221 SNEF FDA UDIMDSC-8358 RL FDA UDIVANTAGEVIEW 2.0 DECODER FDA UDIMDFC-8232 3HB FDA UDI
Identifiers
- Catalog Number
- K9352360 FDA UDIK9352172 FDA UDIK9352860 FDA UDIK9352422 FDA UDIK9307931 FDA UDIK9352391 FDA UDIK9301100A FDA UDIK9300390A2X FDA UDIK9300372C1X FDA UDIK9307939 FDA UDI600301482 FDA UDIK9352290 FDA UDI
- Primary DI / UDI-DI
- 05415334042841 EUDAMED05415334001824 EUDAMED05415334034921 EUDAMED05415334001732 EUDAMEDFDA UDI05415334045781 EUDAMED05415334034549 EUDAMED05415334026605 EUDAMED05415334031838 EUDAMEDFDA UDI05415334001305 EUDAMEDFDA UDI05415334045217 EUDAMEDFDA UDI05415334042414 EUDAMEDFDA UDI05415334001947 EUDAMEDFDA UDI05415334031883 EUDAMEDFDA UDI05415334056244 EUDAMEDFDA UDI05415334050372 EUDAMEDFDA UDI05415334054998 EUDAMEDFDA UDI05415334001848 EUDAMEDFDA UDI05415334053663 EUDAMEDFDA UDI05415334029415 EUDAMEDFDA UDI05415334061750 EUDAMED05415334001428 EUDAMED05415334056411 EUDAMED05415334053168 EUDAMED
- Basic UDI-DI
- 5415334_Surgical-BE_9B EUDAMED5415334_Pathology_X4 EUDAMED5415334_Tomo_KW EUDAMED5415334_Dental_9N EUDAMED5415334_NexxisOR_P4 EUDAMED5415334_Patho-IVD_VT EUDAMED
- 510(k) Number
- K173381 FDA UDI
- FDA Product Code
- KQM FDA UDIPZZ FDA UDIPSY FDA UDIPGY FDA UDIDXJ FDA UDI
- EMDN Code
- Z11900802 BIOIMAGING VIEWING MONITORS EUDAMEDZ11900801 BIOIMAGING DIAGNOSTIC REPORT VIEWING MONITORS EUDAMEDZ12019099 VARIOUS INSTRUMENTS FOR GENERAL AND MULTIDISCIPLINARY SURGERY - OTHER EUDAMEDZ11069099 VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - OTHER EUDAMEDW0202050380 LABORATORY INSTRUMENTS FOR MICROSCOPIC INVESTIGATIONS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Image display unit, colour FDA UDIDigital pathology image display unit IVD FDA UDIRadiology picture archiving and communication system workstation FDA UDIOperating room audiovisual data/device management system FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDIClass IIa EUDAMEDClass A EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4160 FDA UDI864.3700 FDA UDI892.2050 FDA UDI870.2450 FDA UDI
- Market of Registration
- Belgium 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
Microbial Substances
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
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
Yes
FDA UDIFDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Barco by Barco NV — Class I — IVDR, MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 5415334_Surgical-BE_9B | Class I | Active |
| EUDAMED | European Union | CE/MDR | 5415334_Surgical-BE_9B | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Barco NV
- EUDAMED SRN
- BE-MF-000000690
Sources (36)
- EUDAMED a14afff3-6d1c-4347-854f-f501346ad034 61 fields · synced Sep 17, 2026
- EUDAMED 92feeaa8-f37a-4054-91b9-b5520d51eb61 61 fields · synced May 16, 2026
- EUDAMED f45d6f96-1628-4773-aba5-43fd4331dd6c 61 fields · synced May 17, 2026
- EUDAMED 8a836d5b-04d9-4b9f-902d-225457b80f62 61 fields · synced May 17, 2026
- EUDAMED 5787754a-7475-4bb5-b03a-ae4436b74e93 61 fields · synced May 17, 2026
- EUDAMED 2142e422-0351-46bf-ad66-6a7ef8402407 61 fields · synced May 18, 2026
- EUDAMED c1f4c100-7ba5-49d3-b467-521b3c588957 61 fields · synced May 18, 2026
- FDA UDI e9345dc5-5ae4-4e59-ab76-1f8e915b24ff 35 fields · synced May 29, 2026
- FDA UDI bbdb0413-f36a-4a92-a481-f9ef4b3100bf 35 fields · synced May 29, 2026
- FDA UDI 929997bc-f624-45fb-816b-d2fd3cddd950 35 fields · synced May 30, 2026
- FDA UDI 33de9d04-75df-4b18-93b8-1fc2f19b8aad 35 fields · synced May 30, 2026
- FDA UDI fb04c584-7e18-476c-a5a0-8e52cb5bbbc2 35 fields · synced May 30, 2026
- FDA UDI a3e77d49-c8d9-4b95-b247-2f68a696d5e2 35 fields · synced May 30, 2026
- FDA UDI 3a2b3bb8-4b1d-4908-a6cc-3222c3449442 35 fields · synced May 30, 2026
- FDA UDI 98cf0f83-b164-470d-b768-c2cf1d7cbc95 35 fields · synced May 30, 2026
- FDA UDI 1db0ca43-dc0f-4bb0-a62b-6707e96d28eb 35 fields · synced May 30, 2026
- FDA UDI 6025ea94-84a0-4acd-b348-4d3d094ff700 35 fields · synced May 30, 2026
- FDA UDI 068520cc-0aaa-4821-b276-bef4778e868d 35 fields · synced May 30, 2026
- FDA UDI 4bd07dbe-cc33-4130-ac05-b0a0c9e13bd3 36 fields · synced May 30, 2026
- FDA UDI 5f3c5061-4667-4177-b9ff-b144785b3ce9 35 fields · synced May 30, 2026
- EUDAMED b6d4fa7e-f049-4e6e-8399-cebeef045a5c 61 fields · synced Jun 20, 2026
- EUDAMED e82346d0-5a43-4aff-beb1-3c3688577566 61 fields · synced Jul 8, 2026
- EUDAMED 64d71e86-0951-47ae-be49-a8a12c4b96fc 61 fields · synced Jul 9, 2026
- EUDAMED e0725ba7-fe57-434a-8bbb-d68b56d9decb 61 fields · synced Jul 9, 2026
- EUDAMED 10a0f8c2-e658-4272-a7c1-741820facdd4 61 fields · synced Jul 9, 2026
- EUDAMED 2cd6f161-c790-4a5c-ac9a-a98629f5387f 61 fields · synced Jul 9, 2026
- EUDAMED 1550e618-c1db-45b2-ad42-9276dd88bbc2 61 fields · synced Jul 10, 2026
- EUDAMED 323b574a-2fc8-42b8-b0cd-b3ab3b5bc862 61 fields · synced Jul 11, 2026
- EUDAMED f9c7bdb4-41d2-44fb-9a64-5a7cb5881e41 61 fields · synced Jul 14, 2026
- EUDAMED b85653ce-d9a2-4620-87c5-dd237cc493ba 61 fields · synced Jul 19, 2026
- EUDAMED cca794f1-223f-4126-9ac7-8a83f52dadc7 61 fields · synced Jul 24, 2026
- EUDAMED 19cf53da-f0eb-41e7-97c8-43635c79942d 61 fields · synced Jul 26, 2026
- EUDAMED 336a1aad-215f-49e2-98bd-f7aba648118d 61 fields · synced Jul 28, 2026
- EUDAMED 8d88e0f7-0f6e-4bd0-aa5d-911f6c1b326f 61 fields · synced Jul 29, 2026
- EUDAMED 8297bac4-3271-4b09-bcd0-beb77b5477dc 61 fields · synced Aug 3, 2026
- EUDAMED 4032ff39-8da5-4c7e-9c39-c7f977ba32d4 61 fields · synced Aug 4, 2026