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Imaging (ZEOS)
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref 84-10-5310Ref 84-10-5321Ref 84-20-50035Ref 84-10-5201Ref 84-10-5330Ref 84-20-50036
Identity
- Trade Name
- Zeos EUDAMEDImaging (ZEOS) FDA UDI
- Generic Name
- Fibreoptic light cable FDA UDIEndoscopic light source adaptor FDA UDI
- Device Name
- 4K HDR Camera System EUDAMEDLight Guide and Adapter EUDAMEDLIGHTCABLE 3M GREY W/ STORZ ADAPTER FDA UDIACMI ADAPTER FDA UDIWOLF ADAPTER FDA UDI
- Model / Reference
- 84-20-50036 EUDAMEDFDA UDI84-20-50035 EUDAMEDFDA UDI84-10-5310 EUDAMED84-10-5321 EUDAMED84-10-5201 EUDAMED84-10-5330 EUDAMED84-20-5004 FDA UDI
- Description
- LIGHTCABLE 3M GREY W/ STORZ ADAPTER FDA UDIACMI ADAPTER FDA UDIWOLF ADAPTER FDA UDI
Identifiers
- Catalog Number
- 84-20-5004 FDA UDI84-20-50036 FDA UDI84-20-50035 FDA UDI
- Primary DI / UDI-DI
- 00853460007184 EUDAMEDFDA UDI00853460007177 EUDAMEDFDA UDI00812231034620 EUDAMED00812231034569 EUDAMED00812231034538 EUDAMED00812231034651 EUDAMED00853460007153 FDA UDI
- Basic UDI-DI
- 0812231038X-10-XXXXWW EUDAMED0812231038X-20-XXXXXF EUDAMED
- Direct Marketing DI
- 00812231034620 EUDAMED00812231034569 EUDAMED00812231034651 EUDAMED
- FDA Product Code
- FST FDA UDIFFY FDA UDI
- EMDN Code
- Z12020405 SURGICAL CAMERAS EUDAMEDZ12020480 INSTRUMENTS FOR THE ACQUISITION AND MANAGEMENT OF ENDOSCOPIC AND MINIMALLY INVASIVE SURGERY IMAGES - HARDWARE ACCESSORIES EUDAMEDZ12020401 INTEGRATED SYSTEMS FOR THE ACQUISITION AND MANAGEMENT OF ENDOSCOPIC AND MINIMALLY INVASIVE SURGERY IMAGES EUDAMED
- GMDN Term
- Fibreoptic light cable FDA UDIEndoscopic light source adaptor FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDIClass II FDA UDI
- Regulation Number
- 878.4580 FDA UDI876.1500 FDA UDI
- Market of Registration
- Netherlands 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
EUDAMEDEUDAMED
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
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
No
FDA UDIFDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Fibreoptic light cable
Imaging (ZEOS) by Santa Barbara Imaging Systems, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Fibreoptic light cable.
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- ASSI — ACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORP. · Class II
- JEDMED — JEDMED Instrument Company · Class I
- Surgical Direct — SURGICAL DIRECT, INC. · Class II
- FENTEX — FENTEX medical GmbH · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Santa Barbara Imaging Systems, Inc.
Sources (9)
- FDA UDI c9baf4a2-1faa-4fe4-b436-54385e3b7da7 35 fields · synced Jul 31, 2026
- FDA UDI c2b1388b-e457-439c-85ea-7592bc7fb7af 35 fields · synced May 29, 2026
- FDA UDI 0530b96e-cf76-43d5-b191-8535ea66bff3 35 fields · synced May 30, 2026
- EUDAMED f9cfc60c-7d23-439e-8732-c9e80135a767 61 fields · synced Jun 20, 2026
- EUDAMED 24f4a376-3305-4636-839c-0181ccb4558e 61 fields · synced Jul 13, 2026
- EUDAMED 4ad7f2a5-3d79-4bb9-9fe7-7f23eb65ce21 61 fields · synced Jul 15, 2026
- EUDAMED 59ff32fc-79bc-41c9-b2e1-b311e8dcb1a4 61 fields · synced Jul 18, 2026
- EUDAMED 7c5845f4-ed96-4dc1-8bed-0a1a7da6d8e7 61 fields · synced Jul 26, 2026
- EUDAMED b58c0993-e4ce-478b-a2d5-81999362958c 61 fields · synced Jul 31, 2026