Ningbo Albert Novosino Co.,Ltd.

Pad printing, screen printing, laser printing and other technologies are available.

The MOQ is 3,000 pieces for the small-sized balls and 1,000 pieces for the large-sized ones. A Pantone color code is required for color specification.

A UDI (Unique Device Identification) is a globally standardized coding system for medical devices, consisting of two mandatory, complementary components to enable full-life-cycle traceability and regulatory compliance. UDI=PI+DI ①DI (Device Identifier)It is the static component of a UDI, used to identify fixed and unchangeable information about a medical device, including the manufacturer, product model, product version, and packaging level. The DI remains consistent throughout the entire life cycle of the product, and each DI corresponds to a unique product specification at a specific packaging level. It must be registered and filed in the corresponding regulatory database (e.g., EUDAMED for the EU, GUDID for the US) by the manufacturer, and cannot be modified without regulatory approval. ②PI (Production Identifier)It is the dynamic component of a UDI, used to record variable production-related information that differs by batch or individual unit. Common PI data elements include production date, batch number, serial number, expiration date, and sterilization date (for sterile devices). The PI is tailored to the product’s risk level and production management needs; for example, high-risk implantable devices are required to include a unique serial number in the PI, while general medical devices may only need to contain batch number and expiration date.

The lead time is 15–30 days for standard packaging, and 30–50 days for customized packaging.

The MDR (Medical Device Regulation) explicitly stipulates that there is no provision allowing any party other than the manufacturer to assume obligations related to UDI. All responsibilities—including UDI application, labeling, and submission—shall be borne entirely by the manufacturer.

Many of our importers have already associated themselves with us on EUDAMED. This association is entirely self-operated by the importers via their own accounts, and does not require any authorization or application from our side. Therefore, the specific operational procedures shall be explored by the customers on their own initiative. It is a statutory obligation for customers to register an importer account first.