Morphle Labs maintains rigorous quality management systems and regulatory certifications across its manufacturing operations, product portfolio, and global distribution - ensuring safety, efficacy, and trust for every pathology lab we serve.
Our MorphoLens slide scanner series and Robotome robotic microtome carry CE marking, confirming conformity with applicable EU Medical Device Directives and IVDR Regulations.
MorphoLens Slide Scanner Series
Digital Pathology Whole Slide Scanners
All variants in the MorphoLens product line - including the MorphoLens 1, MorphoLens 6, and MorphoLens 240 - are covered under this CE registration for EU market access.
Robotome
High Throughput Robotic Microtome
The Robotome - delivering consistent 4µm tissue sections at up to 60 blocks per hour - is CE certified for EU distribution and clinical use in pathology labs.
Morphle Labs (manufacturing entity) is certified under the Medical Devices Quality Management System standard by the Dutch Institute of Quality Certifications B.V.
Morphle Labs Inc., our US headquarters, is registered with the US Food & Drug Administration as a medical device establishment.
Morphle Labs Inc. is registered with the U.S. Food & Drug Administration (FDA) as a medical device establishmentwithin the United States. This registration is renewed annually in compliance with 21 CFR Part 807.
Morphle Labs holds the following verified certifications: (1) ISO 13485:2016 — Morphle Labs Private Limited, Bengaluru. Certificate No. 00325/01. Issued 03 Jul 2025. Valid until 02 Jul 2028. Certifying body: DIQC B.V. (UAF CB-MS-8426). Scope: design, manufacturing, sales, distribution, installation and servicing of digital laboratory microscopes and microtomes for IVD use, including software. (2) CE — MorphoLens Scanner Series. NOTIS Reg. No. 20250637. Covers MorphoLens 1, 6, 240, HemoLens. (3) CE — Robotome (Robotic Microtome). NOTIS Reg. No. 20253966. (4) FDA Establishment Registration — Morphle Labs Inc. (US entity). Reg. No. 3033165977.
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