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Pen Injector
EUDAMEDClass IIb (EU MDR)
Ref WH-RA62, WH-RA63, WH-RA64, WH-RA65, WH-RA66
Identity
- Trade Name
- Pen Injector EUDAMED
- Device Name
- Pen Injector EUDAMED
- Model / Reference
- WH-RA62, WH-RA63, WH-RA64, WH-RA65, WH-RA66 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974864480619 EUDAMED
- Basic UDI-DI
- 697486448PI013PQ 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 | 697486448PI013PQ | 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 e4d9bb32-a5d5-460c-ae13-925fcf69bfad 61 fields · synced Jul 8, 2026
- EUDAMED e4d9bb32-a5d5-460c-ae13-925fcf69bfad-1 61 fields · synced Jun 10, 2026