Laser marking medical devices at component level: we machine your part and mark the UDI, lot or serial number your drawing specifies, for OEMs and contract manufacturers. Each mark is verified.
MedCNCParts, the medical division of DEK, machines your component and ships it laser marked with the UDI, lot or serial number or logo your drawing specifies. OEMs and contract manufacturers receive inspected parts on one lot record, under an ISO 13485 quality system.
The OEM owns UDI assignment and its GUDID and EUDAMED submissions; we mark the content it supplies and record which lots go on which parts. We supply marked parts; we do not sell marking equipment.
Annealing on stainless and titanium, engraving where the mark must survive polishing; the type is frozen at first article.
On stainless parts, marking is followed by passivation per ASTM A967 / A967M, with method and test agreed with the OEM.
Codes graded per ISO/IEC 29158 against the OEM's minimum grade; grades go on the inspection report, available on request.
Machining, finishing, marking and inspection share one traveler, so the lot number on the mark is never re-keyed.
On stainless steel, an annealing mark alters the oxide layer and can leave heat tint; engraving exposes fresh metal. Either can lower corrosion resistance at the mark, so the sequence is marking, then passivation after laser marking per ASTM A967 / A967M (or ASTM A380 when the drawing calls for it), with method and test agreed with the OEM.
Electropolishing gives a uniform surface for contrast; whether the mark goes before or after it is decided per part (see electropolishing vs passivation). The OEM validates that the mark survives its reprocessing and sterilization cycles.
Laser marking runs on the components we machine to OEM drawings; implant parts are an additional capability.
Reusable instruments are the main case for a permanent, direct UDI mark on the part itself.
Diagnostic and laboratory housings, manifolds and brackets marked with serial or part numbers.
Bone screws and other implant parts; biological evaluation, sterilization validation and clearance stay with the OEM.
“We’ve worked with other suppliers before, but MedCNCParts’ laser marks consistently last through sterilization and repeated handling. It’s a huge relief knowing our parts remain fully traceable, and it saves our team time during audits and inspections. We are very satisfied with your service.”
“Received our first batch today, and I’m really impressed. The UDI codes are crisp and clear, and every part meets all our specifications. We can’t wait to receive the next batches!”
“I was concerned about marking tiny parts, but MedCNCParts handled every mark smoothly, accurately, and traceably. Your attention to detail on small components is really great, and it gives us confidence that every part will meet our quality requirements.”
Send the UDI content and layout with your drawing: DI and PI fields, symbol size and location.
MedCNCParts manufactures components to customer specifications; it does not design or market medical devices.
Under 21 CFR 801.45, a device intended to be used more than once and reprocessed before each use must bear a permanent UDI on the device itself, with listed exceptions. The OEM determines whether it applies and what to mark.
It can on stainless steel. Annealed marks and a defined re-passivation step per ASTM A967 limit the effect, and the OEM validates durability through its reprocessing cycles.
No. The OEM obtains the DI from GS1, HIBCC or ICCBBA, manages its GUDID and EUDAMED data and supplies the content; the parts are marked with that content and verified before shipment.
Marking is set up around the parts we machine, on the same lot record. Customer-supplied parts are reviewed case by case.
Codes are graded per ISO/IEC 29158, or ISO/IEC 15415 when specified, and grades are recorded on the inspection report, available on request.
Titanium, 316L / 316 and 17-4PH stainless steel, and medical plastics such as PEEK and PPSU, each confirmed on a sample.
