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Sign in to claim this brandCarl Zeiss Meditec AG
United States·DE-MF-000007732
Last updated September 17, 2026
Part of Carl Zeiss Meditec SAS
What Carl Zeiss Meditec AG makes
Carl Zeiss Meditec AG manufactures reusable and single-use sterile drapes for medical and surgical settings, as well as general-purpose and neurosurgical microscopes for precision intraoperative procedures. The company also produces ophthalmic imaging devices, including fundus cameras, and femtosecond laser systems for refractive eye surgery. Intraoperative and postoperative therapeutic X-ray systems, including spherical and flat applicators, are part of its portfolio.
The company’s devices are classified under EU regulations as Class I, Class IIa, IIb, and III, and are listed in the EUDAMED database. In the US, they appear in FDA registries for 510(k), PMA, and UDI submissions. The manufacturer is based in Germany.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Carl Zeiss Meditec AG manufacture?
Carl Zeiss Meditec AG produces a range of medical devices, including reusable and single-use sterile drapes for surgical and medical environments. Their portfolio also covers precision imaging tools like general-purpose and neurosurgical microscopes, ophthalmic fundus cameras, and femtosecond laser systems for refractive eye surgery. Additionally, they offer intraoperative and postoperative therapeutic X-ray systems, including both spherical and flat applicators.
Where is Carl Zeiss Meditec AG based?
Carl Zeiss Meditec AG is headquartered in Germany. The company’s location in Germany influences its regulatory compliance with EU medical device directives, which classify its products under various risk-based categories such as Class I, Class IIa, IIb, and Class III.
Which regulatory registries list Carl Zeiss Meditec AG’s devices?
Carl Zeiss Meditec AG’s devices are listed in multiple regulatory databases, including the EU’s EUDAMED system for tracking medical devices under EU regulations. In the United States, their devices appear in FDA registries for 510(k) premarket notifications, PMA (Premarket Approval) applications, and UDI (Unique Device Identification) submissions, reflecting their global market presence.
How are Carl Zeiss Meditec AG’s devices classified under EU regulations?
Under EU medical device regulations, Carl Zeiss Meditec AG’s devices are classified into different risk categories: Class I for low-risk items like some drapes, Class IIa and IIb for moderate-risk products such as imaging systems and lasers, and Class III for high-risk devices like certain intraoperative X-ray systems. The classification determines the regulatory requirements for compliance, such as clinical evaluations or conformity assessments.
What determines why some of Carl Zeiss Meditec AG’s devices fall into higher classification categories like Class IIb or Class III?
The classification of Carl Zeiss Meditec AG’s devices into higher risk categories like Class IIb or Class III is based on factors such as the device’s intended use, potential risks to patients, and the level of intervention involved. For example, femtosecond laser systems for refractive surgery or intraoperative X-ray systems are classified as higher risk due to their direct interaction with critical body areas and the precision required to ensure safety and efficacy. These classifications align with EU regulations to ensure appropriate scrutiny and compliance measures.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- United States
- Address
- 5300, Central Parkway, Dublin, United States
- Website
- www.zeiss.com/meditec
- —
- —
- [email protected]
- Phone
- +1 925 336 9395
- PRRC Contact
- Viet Nguyen
- EUDAMED SRN
- DE-MF-000007732
- FDA FEI Number
- —
- DUNS Number
- 342228620
Catalogue (304)
Page 6 of 7| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Stratusoct With Rnfl Normative Database | K030433 | FDA 510(k) | Class II | Active |
| VISULAS green | K181682 | FDA 510(k) | Class II | Active |
| Cirrus Hd-Oct With Retinal Nerve Fiber Layer And Macular Normative Databases, Model 4000 | K083291 | FDA 510(k) | Class II | Active |
| Convivo | K181116 | FDA 510(k) | Class II | Active |
| IOLMaster 700 | K173771 | FDA 510(k) | Class II | Active |
| CIRRUS HD-OCT WITH RETINAL NERVE FIBER LAYER, MACULAR, OPTIC NERVE HEAD, and GANGLION CELL NORMATIVE DATABASES | K111157 | FDA 510(k) | Class II | Active |
| Retina Workplace | K150467 | FDA 510(k) | Class II | Active |
| QEVO System | K232159 | FDA 510(k) | Class II | Active |
| QEVO System with KINEVO 900 | K170667 | FDA 510(k) | Class II | Active |
| IOLMaster 700 | K170171 | FDA 510(k) | Class II | Active |
| CIRRUS™ HD-OCT Model 6000 | K233933 | EUDAMEDFDA 510(k)FDA UDI | Class II | Active |
| Rescan 700, Callisto Eye | K141844 | FDA 510(k) | Class II | Active |
| Blue 400; Blue 400 S | K240215 | FDA 510(k) | Class II | Active |
| At 030 | K180839 | FDA 510(k) | Class II | Active |
| Forum | K213527 | FDA 510(k) | Class II | Active |
| Intrabeam 600 | K162568 | FDA 510(k) | Class II | Active |
| Fluorescence Accessories (YELLOW 560 and INFRARED 800 with FLOW 800 Option) | K231075 | FDA 510(k) | Class II | Active |
| Guided Progression Analysis On The Humphrey Field Analyzer Ii And Ii -i Series | K093213 | FDA 510(k) | Class I | Active |
| Cirrus Hd-Oct | K150977 | FDA 510(k) | Class II | Active |
| Zeiss Cataract Suite Markerless | K141068 | FDA 510(k) | Class II | Active |
| Angioscan (as Stand Alone Instrument) | K951132 | FDA 510(k) | Class II | Active |
| Rescan 700 | K233421 | FDA 510(k) | Class II | Active |
| CALLISTO eye | K180858 | FDA 510(k) | Class II | Active |
| Model Visulas 532s Laser With The Vite Option | K100035 | FDA 510(k) | Class II | Active |
| Intrabeam System With Intrabeam Spherical Applicators | K121653 | FDA 510(k) | Class II | Active |
| Topographic Scanning System Topss | K923742 | FDA 510(k) | Class II | Active |
| INTRABEAM (700); And accessories (INTRABEAM SMART Stand, INTRABEAM SMART Spherical Applicator, INTRABEAM Spherical Sizer Set, INTRABEAM Needle Applicator) | K241174 | FDA 510(k) | Class II | Active |
| Blue 400 | K211346 | FDA 510(k) | Class II | Active |
| CALLISTO eye | K232944 | FDA 510(k) | Class II | Active |
| Gdx Vcc With Ecc Software | K082016 | FDA 510(k) | Class II | Active |
| Visulas Trion Laser System With The Vite Option | K103056 | FDA 510(k) | Class II | Active |
| Viscucam C Digital Camera | K043222 | FDA 510(k) | Class II | Active |
| Iolmaster 500 | K101182 | FDA 510(k) | Class II | Active |
| Retina Workplace | K182318 | FDA 510(k) | Class II | Active |
| Slit Lamps With Sl Cam 5.0 Digital Imaging Solution | K133476 | FDA 510(k) | Class II | Active |
| CALLISTO eye | K231676 | FDA 510(k) | Class II | Active |
| Visumax Laser Keratome | K100253 | FDA 510(k) | Class II | Active |
| Sl 220 | K162684 | FDA 510(k) | Class II | Active |
| Forum Forum Archive Forum Archive & Viewer Forum Assist Match | K122938 | FDA 510(k) | Class II | Active |
| Cirrus Hd-Oct | K181534 | FDA 510(k) | Class II | Active |
| VISULAS combi | K233911 | FDA 510(k) | Class II | Active |
| Callisto Eye | K123464 | FDA 510(k) | Class II | Active |
| Clarus | K191194 | FDA 510(k) | Class II | Active |
| Forum Glaucoma Workplace | K141297 | FDA 510(k) | Class II | Active |
| Visante Oct | K051789 | FDA 510(k) | Class II | Active |
| VISULAS green | K232051 | FDA 510(k) | Class II | Active |
| Quatera 700 | K230858 | FDA 510(k) | Class II | Active |
| Cirrus Photo | K112184 | FDA 510(k) | Class II | Active |
| Quatera 700 | K212241 | FDA 510(k) | Class II | Active |
| Cirrus Photo | K133217 | FDA 510(k) | Class II | Active |
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FDA Recalls (17)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
Carl Zeiss Meditec AG has 17 FDA recall records initiated between May 18, 2009, and January 14, 2022, with statuses recorded as open, classified, or terminated. The reasons cited include manufacturing defects (e.g., dislodged tubes, broken screws), software issues (e.g., incorrect data saving, mislabeled images, suction loss during treatment), labeling errors (e.g., misapplied manuals, incorrect user database values), and failures to obtain pre-market clearance for certain devices. Additional concerns involve potential electrical hazards, packaging anomalies, and distribution of devices without required approvals.
AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Jan 14, 2022 | Z-0723-2022 | — | open, classified | Optic nerve head angiography scan to be turned off due to its distribution without pre-market clearance. |
| Jul 8, 2021 | Z-2227-2021 | — | open, classified | Due to failure to acquire pre-market clearance for its high resolution tomographic/biomicroscope imaging device (Model 6000) prior to commercializing the device. |
| Dec 6, 2018 | Z-0680-2020 | — | terminated | VisuMax devices with software version 2.10.13 and activated SW-Module ReLEx (SMILE) option may experience a software issue. In case of a suction loss during treatment the software allows the user to choose the option immediate restart or restart treatment. Suction loss can occur in phase 1 through phase 5. The software defect refers to Phase 2 (between 10% and 100% of lower lenticule cut) only. The software offers a flap cut, but due to the software issue it performs a cap cut instead of a flap cut if the user proceeds. |
| Oct 16, 2018 | Z-0770-2020 | — | terminated | Under certain fault conditions, the existing design may expose the operator to a hazardous voltage when contacting the metal enclosure (including mounting screws) around the up/down switch. |
| Oct 23, 2013 | Z-0334-2014 | — | terminated | The user database delivered for download contained an erroneous value. Specifically the "aO" constant of the lens AMO Sensar AR40E is listed as "0.0" in the internal lens database of the IOLMaster. The correct value is -2.420. This could lead to the implantation of lens with a wrong diopter value. |
| Oct 23, 2013 | Z-0333-2014 | — | terminated | The user database delivered for download contained an erroneous value. Specifically the "aO" constant of the lens AMO Sensar AR40E is listed as "0.0" in the internal lens database of the IOLMaster. The correct value is -2.420. This could lead to the implantation of lens with a wrong diopter value. |
| Apr 18, 2013 | Z-1440-2013 | — | terminated | Carl Zeiss Meditec is conducting a field corrective action for its OPMI Pentero C surgical microscope system. During a routine inspection, one microscope installation was found to have 3 (three) broken screws out of 6 (six) in the lower section of the ceiling mount. |
| Oct 25, 2012 | Z-0404-2013 | — | terminated | A manufacturing defect has been identified which could results in the small tube becoming dislodged between the luer fitting and the check valve. |
| Oct 25, 2012 | Z-0405-2013 | — | terminated | A manufacturing defect has been identified which could results in the small tube becoming dislodged between the luer fitting and the check valve. |
| Oct 25, 2012 | Z-0406-2013 | — | terminated | A manufacturing defect has been identified which could results in the small tube becoming dislodged between the luer fitting and the check valve. |
| Sep 26, 2011 | Z-0105-2012 | — | terminated | An incorrect nut and bolt set was used in the axis three (3) spring assembly of the OPMI VARIO 700 surgical microscope distributed to three US locations. |
| Sep 12, 2011 | Z-3275-2011 | — | terminated | Some third party surgical drapes have optically active protective lenses that could affect the ZEISS surgical microscope position information that is passed on to third party navigation systems. |
| Jul 1, 2011 | Z-2989-2011 | — | terminated | Carl Zeiss Meditec received a report that the INTRABEAM 20 x 20 cm sterile shield's packaging looked wet inside. Investigation found the substance to be Triethylene Glycol, |
| Mar 10, 2011 | Z-2127-2011 | — | terminated | A software defect exists in versions 5.0.0 and 5.1.0 where when following a specific workflow, exam data may be saved under the name of the first patient |
| Mar 10, 2011 | Z-2126-2011 | — | terminated | A software defect exists in versions 5.0.0 and 5.1.0 where when following a specific workflow, exam data may be saved under the name of the first patient |
| Jul 31, 2009 | Z-2048-2009 | — | terminated | Mis-labeled image. A bug in version 6.0.0 software and 6.0.0 software kit used with Stratus OCT Model 3000 can produce a report that incorrectly labels OD or OS. |
| May 18, 2009 | Z-0904-2011 | — | terminated | Potential Retina Damage-- An error in the user manual may result in misapplied filter and injury during treatment. |