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Penlight
EUDAMEDClass I (EU MDR)
Ref SW-PL01,SW-PL07,SW-PL16, SW-45,SWPL48,SW-PL49, SW-PL78
Identity
- Trade Name
- PENLIGHT EUDAMED
- Device Name
- PENLIGHT EUDAMED
- Model / Reference
- SW-PL01,SW-PL07,SW-PL16, SW-45,SWPL48,SW-PL49, SW-PL78 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978724260014 EUDAMED
- Basic UDI-DI
- 697872426002P3 EUDAMED
- Direct Marketing DI
- 06978724260014 EUDAMED
- EMDN Code
- Z120499 GENERAL MEDICINE INSTRUMENTS - 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 Ruian Sunnyworld International Trade 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 | 697872426002P3 | Class I | Active |
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Manufacturer
- Manufacturer
- Ruian Sunnyworld International Trade Co., Ltd.
- EUDAMED SRN
- CN-MF-000028674
- Authorised Representative
- Luxus Lebenswelt GmbH DE-AR-000005110
Sources (2)
- EUDAMED 39cbff3b-e672-40cb-b29c-bec2deed2004 61 fields · synced Oct 6, 2026
- EUDAMED 39cbff3b-e672-40cb-b29c-bec2deed2004-1 61 fields · synced Jun 10, 2026