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Polymed
EUDAMEDClass IIa (EU MDR)
Ref BY-QN-01Model BY-QN-00,BY-QN-01,BY-QN-02,BY-QN-03,BY-QN-10,BY-QN-11,BY-QN-12,BY-QN-13Ref BY-5Model BY-RGB-P-1/BY-RGB-P-2/BY-RGB-P-3/BY-GL-1/BY-GL-2/ BY-GL-3/BY-GL-4/BY-GL-5/BY-1/BY-2/BY-3/BY-4/BY-5Ref BY-QN-02Ref BY-QN-03Ref BY-GL-1
Identity
- Trade Name
- POLYMED EUDAMED
- Model / Reference
- BY-QN-00,BY-QN-01,BY-QN-02,BY-QN-03,BY-QN-10,BY-QN-11,BY-QN-12,BY-QN-13 EUDAMEDBY-QN-01 EUDAMEDBY-RGB-P-1/BY-RGB-P-2/BY-RGB-P-3/BY-GL-1/BY-GL-2/ BY-GL-3/BY-GL-4/BY-GL-5/BY-1/BY-2/BY-3/BY-4/BY-5 EUDAMEDBY-5 EUDAMEDBY-QN-02 EUDAMEDBY-QN-03 EUDAMEDBY-GL-1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06951467493093 EUDAMED06951467493116 EUDAMED06951467491136 EUDAMED06951467493109 EUDAMED06951467493123 EUDAMED06951467491044 EUDAMED
- Basic UDI-DI
- 69514674150001XB EUDAMED69514674110001VX EUDAMED
- EMDN Code
- R03020101 ANAESTHESIA BALLOONS EUDAMEDR040102 ANTIBACTERIAL AND ANTIVIRAL RESPIRATORY FILTERS HUMIDIFIERS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Czechia EUDAMEDGermany EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDEUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Polymed by Ningbo Boya Medical Equipment Co., Ltd — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 69514674150001XB | Class IIa | Active |
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Manufacturer
- Manufacturer
- Ningbo Boya Medical Equipment Co., Ltd
- EUDAMED SRN
- CN-MF-000032282
- Authorised Representative
- Caretechion GmbH DE-AR-000005946
Sources (6)
- EUDAMED cbac7d02-d086-4baa-ba8c-b2f0e192b141 61 fields · synced Aug 2, 2026
- EUDAMED dde86306-6284-4dec-86e0-4f859c2c63dd 61 fields · synced May 16, 2026
- EUDAMED 11a2d761-5de6-4062-9c1b-e83bd79b4419 61 fields · synced May 17, 2026
- EUDAMED 2e4f78cd-0ad1-41d8-93a6-76ed01729999 61 fields · synced May 17, 2026
- EUDAMED e753b59d-eb77-41f9-b3a6-9bd40c0492f1 61 fields · synced May 17, 2026
- EUDAMED 349e7212-87e9-4034-a9b8-c0cae3c10bd1 61 fields · synced May 18, 2026