PROSPERITY BIOTECH Obtains EUDAMED SRN CN-MF-000055654 for EU Medical Device Compliance
PROSPERITY BIOTECH Obtains EUDAMED SRN CN-MF-000055654 for EU Medical Device Market Access
PROSPERITY BIOTECH (Shandong) Co., Ltd. has successfully completed its Actor registration in EUDAMED, the European Database on Medical Devices, and has obtained the manufacturer Single Registration Number CN-MF-000055654.
This registration supports our long-term commitment to EU MDR 2017/745 and IVDR 2017/746 compliance. As EUDAMED becomes increasingly important for medical device traceability, UDI registration, CE certificate management and market surveillance, a valid SRN provides our European partners with stronger regulatory transparency and supply chain confidence.
Product Registration Information
- Product Name: Medical Washer Disinfector
- Product Code: Z12011301 – Cleaning and Disinfection Equipment
- Basic UDI-DI: 697953701BS0101G3
- Manufacturer SRN: CN-MF-000055654
The Basic UDI-DI helps identify the device family in the EUDAMED system and supports product traceability, technical documentation, Declaration of Conformity preparation and EU market access requirements.
Why This Matters for EU Buyers
For EU distributors, importers, authorised representatives, hospitals and laboratory equipment buyers, working with an EUDAMED-registered manufacturer helps improve supplier verification and regulatory documentation review.
Our SRN supports:
- Manufacturer identity verification
- UDI and device registration preparation
- CE and technical documentation alignment
- Better communication with EU authorised representatives and importers
- Stronger traceability and supply chain transparency
- More reliable sourcing from a China-based medical device manufacturer
EUDAMED Mandatory Modules
From May 28, 2026, the first four EUDAMED modules become mandatory for relevant operators placing medical devices and IVD products on the EU market:
1. Actor Registration
2. UDI / Device Registration
3. Notified Bodies and Certificates
4. Market Surveillance
By obtaining SRN CN-MF-000055654, PROSPERITY BIOTECH has completed the key first step for further EUDAMED-related compliance work.
Source EU-Compliant Medical Devices From PROSPERITY BIOTECH
PROSPERITY BIOTECH supplies laboratory equipment, medical-related instruments, in-vitro diagnostic consumables and medical disposables to global markets.
If you are looking for a China-based medical device manufacturer with EUDAMED Actor registration, please contact our team to request SRN verification information, product registration details and supporting compliance documents.
Important Note
EUDAMED SRN does not replace CE certification. The SRN identifies the manufacturer or economic operator in EUDAMED, while CE marking is related to product-level conformity assessment. Product compliance depends on product classification, intended use and applicable EU MDR or IVDR requirements.
FAQ
- What is EUDAMED SRN CN-MF-000055654?
CN-MF-000055654 is the EUDAMED Single Registration Number assigned to PROSPERITY BIOTECH (Shandong) Co., Ltd. as a registered manufacturer.
- Does EUDAMED SRN replace CE certification?
No. SRN is manufacturer registration, while CE marking is product-level conformity assessment.
- What product information has been prepared?
One product example is Medical Washer Disinfector, product code Z12011301, with Basic UDI-DI 697953701BS0101G3.
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