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Pen Injector
EUDAMEDClass IIb (EU MDR)
Ref WH-RA57, WH-RA58, WH-RA59, WH-RA60, WH-RA61
Identity
- Trade Name
- Pen Injector EUDAMED
- Device Name
- Pen Injector EUDAMED
- Model / Reference
- WH-RA57, WH-RA58, WH-RA59, WH-RA60, WH-RA61 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974864480565 EUDAMED
- Basic UDI-DI
- 697486448PI012PN EUDAMED
- EMDN Code
- A020203 CARTRIDGE SYRINGES EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Pen Injector by Jiangsu Wan Hai Medical Instruments 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 | 697486448PI012PN | Class IIb | Active |
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Manufacturer
- Manufacturer
- Jiangsu Wan Hai Medical Instruments Co., Ltd
- EUDAMED SRN
- CN-MF-000037576
- Authorised Representative
- Share info GmbH DE-AR-000005132
Sources (2)
- EUDAMED b2a118bb-0e98-41d9-a13c-6771f97d7376 61 fields · synced Jul 14, 2026
- EUDAMED b2a118bb-0e98-41d9-a13c-6771f97d7376-1 61 fields · synced Jun 9, 2026