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Carl Zeiss Meditec AG

United States·DE-MF-000007732

Last updated September 17, 2026

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
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +1 925 336 9395
PRRC Contact: Viet Nguyen
EUDAMED SRN: DE-MF-000007732
FDA FEI Number: —
DUNS Number: 342228620

Catalogue (304)

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Device	Model / Reference	Registries	Class	Status
INTRABEAM® Water Phantom	304534-7000-600	FDA UDI	Class I	Active
OPMI® Drapes sterile	306071-0000-000	FDA UDI	Class II	Active
At 030	AT 030	FDA UDI	Class II	Active
INTRABEAM SMART Spherical Applicator	309120-9015-00	FDA UDI	Class II	Active
IOLMaster 700	IOLMaster 700	FDA UDI	Class II	Active
Humphrey Field Analyzer 3 (HFA3)	HFA3 Review Software	FDA UDI	Class I	Active
Sterilizable cap, 25 mm	305810-0111-810	FDA UDI	Class II	Active
INTRABEAM SMART Spherical Applicator (45mm)	309120-9045-000	FDA UDI	Class II	Active
INFRARED 800 with FLOW® 800 Option	7012	FDA UDI	Class II	Active
Qevo	7212	FDA UDI	Class II	Active
INTRABEAM® Spherical Applicator 4.0 cm	304534-6000-562	FDA UDI	Class II	Active
Foot Switch Drapes	326012-0000-000	FDA UDI	Class II	Active
Ksk 150 Fc	302303-0000-000	FDA UDI	Class II	Active
Visucam 524	VISUCAM 524	FDA UDI	Class II	Active
OPMI® Drapes sterile	306075-0000-000	FDA UDI	Class II	Active
Sterilizable sleeve	305935-0303-810	FDA UDI	Class II	Active
Artevo 800	6647	FDA UDI	Class I	Active
INFRARED 800 with FLOW® 800 Option	302581-9245-000 302581-9250-000 302581-9246-000	FDA UDI	Class II	Active
INTRABEAM® Spherical Applicator 1.5 cm	304534-6000-557	FDA UDI	Class II	Active
FORUM ASSIST match	1.4.1	FDA UDI	Class II	Unknown
INTRABEAM SMART Spherical Applicator	309120-9025-000	FDA UDI	Class II	Active
OPMI® Drapes sterile	326082-0000-000	FDA UDI	Class II	Active
CIRRUS photo	CIRRUS photo 800	FDA UDI	Class II	Active
Kinevo 900 S	6409	FDA UDI	Class I	Active
Phaco Set Plus 21g, Flared, 30°	303060-1025-000	FDA UDI	Class II	Active
OPMI® Drapes sterile	326018-0000-000	FDA UDI	Class II	Active
INTRABEAM® Spherical Applicator 2.0 cm	304534-6000-558	FDA UDI	Class II	Active
S100 / OPMI pico	000000-1420-191	FDA UDI	Class I	Active
Visumax	VISUMAX 800 or 09511	FDA UDI	Class III	Active
Sterile Sheath for CONVIVO	302732-0530-000	FDA UDI	Class II	Active
Opmi® Pentero® 800	302582-9903-000	FDA UDI	Class I	Active
Smartdrape	306028-0000-000	FDA UDI	Class II	Active
OPMI® Drapes	326044-0000-000	FDA UDI	Class II	Active
Contact guard (EyeMag Smart)	304111-0180-000	FDA UDI	Class II	Active
Quattro Cassette	303061-9015-000	FDA UDI	Class II	Active
Drapes	326038-0000-000	FDA UDI	Class II	Active
Humphrey FDT	710	FDA UDI	Class I	Unknown
Qevo Ecu	7213	FDA UDI	Class II	Active
miLOOP	303071-9090-000	FDA UDI	Class I	Active
FORUM Viewer App	FORUM Viewer App	FDA UDI	Class I	Active
Humphrey Matrix	800	FDA UDI	Class I	Unknown
Single-use lenses for RESIGHT, ULTRA WIDE-ANGLE LENS	302721-9137-000	FDA UDI	Class I	Active
EyeMag Classic	000000-2560-688	FDA UDI	Class I	Active
S7 / OPMI PROergo	000000-1103-022	FDA UDI	Class I	Active
Ulite Phaco Handpiece	303060-0001-000	FDA UDI	Class II	Active
S100 / OPMI pico	000000-1095-094	FDA UDI	Class I	Active
Mel 80	MEL 80	FDA UDI	Class III	Active
INTRABEAM® Spherical Applicator 4.5 cm	304534-6000-563	FDA UDI	Class II	Active
Phaco Set Plus 21g, Biconical, 15°	303060-1023-000	FDA UDI	Class II	Active
S7 / OPMI PROergo	000000-1226-405	FDA UDI	Class I	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.