Identity
- Trade Name
- penlight EUDAMED
- Device Name
- Penlight EUDAMED
- Model / Reference
- HS-401F12 EUDAMEDHS-401F EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970384255997 EUDAMED06970384250046 EUDAMED
- Basic UDI-DI
- 697038425PLTTC EUDAMED
- EMDN Code
- Q0399 ENT DEVICES - OTHER 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
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
penlight by HONSUN (NANTONG) 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 | 697038425PLTTC | Class I | Active |
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Manufacturer
- Manufacturer
- HONSUN (NANTONG) Co., Ltd.
- EUDAMED SRN
- CN-MF-000009428
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED 967bb607-12f9-4b8b-9167-e035b8f82ffa 61 fields · synced Jul 17, 2026
- EUDAMED 42ff6f82-f9ee-4c03-bee1-9c6507470334 61 fields · synced Jul 17, 2026