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Pen Injector
EUDAMEDClass I (EU MDR)
Ref BZ-II (blue)Ref BZ-II (gray)Ref BZ-II (white)Ref BZ-VB
Identity
- Trade Name
- Pen Injector EUDAMED
- Device Name
- Pen Injector EUDAMED
- Model / Reference
- BZ-II (blue) EUDAMEDBZ-II (gray) EUDAMEDBZ-II (white) EUDAMEDBZ-VB EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974573590159 EUDAMED06974573590173 EUDAMED06974573590166 EUDAMED06974573590180 EUDAMED
- Basic UDI-DI
- 697457359372F EUDAMED
- Direct Marketing DI
- 06974573590159 EUDAMED06974573590173 EUDAMED06974573590166 EUDAMED06974573590180 EUDAMED
- EMDN Code
- A020203 CARTRIDGE SYRINGES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
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
Yes
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Pen Injector by Jiangsu Delfu Medical Devices Co., Ltd. — Class I — 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 | 697457359372F | Class I | Active |
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Manufacturer
- Manufacturer
- Jiangsu Delfu Medical Devices Co., Ltd.
- EUDAMED SRN
- CN-MF-000025795
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (4)
- EUDAMED 926301f0-759e-41f1-b614-8425af5cadf2 61 fields · synced Aug 2, 2026
- EUDAMED e597b404-98ba-47f5-b868-220ea6e506bf 61 fields · synced May 17, 2026
- EUDAMED c0be0aec-63c7-41df-b60b-9f40927a5d74 61 fields · synced May 18, 2026
- EUDAMED 433f66da-125b-4141-9472-5ca2a3e3e74c 61 fields · synced May 18, 2026