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Polymed
EUDAMEDClass IIa (EU MDR)
Ref GZ-GL-4Model GZ-GL-1/GZ-GL-2/GZ-GL-3/GZ-GL-3(A)/GZ-GL-3(B)/GZ-GL-4/GZ-GL-4(A)/GZ-GL-4(B)/GZ-GL-5/GZ-GL-5(A)/GZ-GL-5(B)/GZ-GL-6/GZ-GL-7/GZ-GL-8/GZ-GL-9
Identity
- Trade Name
- POLYMED EUDAMED
- Model / Reference
- GZ-GL-1/GZ-GL-2/GZ-GL-3/GZ-GL-3(A)/GZ-GL-3(B)/GZ-GL-4/GZ-GL-4(A)/GZ-GL-4(B)/GZ-GL-5/GZ-GL-5(A)/GZ-GL-5(B)/GZ-GL-6/GZ-GL-7/GZ-GL-8/GZ-GL-9 EUDAMEDGZ-GL-4 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06951467490061 EUDAMED
- Basic UDI-DI
- 69514674120001WA EUDAMED
- EMDN Code
- R040101 ANTIBACTERIAL AND ANTIVIRAL RESPIRATORY FILTERS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Category: Secretion suction kit
Polymed by Ningbo Boya Medical Equipment Co., Ltd — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 69514674120001WA | 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 (1)
- EUDAMED 7e48de2e-c942-4e3f-bbf9-3a65c6c501e0 61 fields · synced Jun 19, 2026