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easyEndo™ Powered cartridges
EUDAMEDClass IIb (EU MDR)
Ref PN45BModel PN45M, PN45W, PN45B, PN45C, PN45G, PN60M, PN60W, PN60B, PN60C, PN60G
Identity
- Trade Name
- easyEndo™ Powered cartridges EUDAMEDeasyEndo™ E-Lite Single Use Cartridge EUDAMED
- Device Name
- cartridges EUDAMEDSingle Use Cartridges EUDAMED
- Model / Reference
- PN45M, PN45W, PN45B, PN45C, PN45G, PN60M, PN60W, PN60B, PN60C, PN60G EUDAMEDPN45B EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06925776106128 EUDAMED
- Basic UDI-DI
- 69257761000803Y8 EUDAMED
- EMDN Code
- H0202010302,H02030106 EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Sutures
Yes
EUDAMED
CMR Substance
Yes
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
easyEndo™ Powered cartridges by Ezisurg Medical Co., Ltd. — Class IIb — 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 | 69257761000803Y8 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Ezisurg Medical Co., Ltd
- EUDAMED SRN
- CN-MF-000006742
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED 66f96ebd-63ce-41c7-b2ef-3f7208da0547 61 fields · synced Jul 15, 2026
- EUDAMED c5420c98-dc06-41cf-a714-e6d9215a514f 61 fields · synced Jul 15, 2026