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Penlight
EUDAMEDClass I (EU MDR)
Ref KT-GF01IModel KT-GF01A, KT-GF01B, KT-GF01C, KT-GF01D, KT-GF01E,KT-GF01F, KT-GF01G,KT-GF01H, KT-GF01K, KT-GF01I, KT-GF01L, KT-GF01M, KT-GF01N,KT-GF01P,KT-GF01Q,KT-GF01R,KT-GF01S,KT-GF01T,KT-GF01U, KT-GF01V, KT-GF01X
Identity
- Device Name
- Penlight EUDAMED
- Model / Reference
- KT-GF01A, KT-GF01B, KT-GF01C, KT-GF01D, KT-GF01E,KT-GF01F, KT-GF01G,KT-GF01H, KT-GF01K, KT-GF01I, KT-GF01L, KT-GF01M, KT-GF01N,KT-GF01P,KT-GF01Q,KT-GF01R,KT-GF01S,KT-GF01T,KT-GF01U, KT-GF01V, KT-GF01X EUDAMEDKT-GF01I EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975338560028 EUDAMED
- Basic UDI-DI
- 697533856penlightQS EUDAMED
- EMDN Code
- V9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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
Category: Device sterilization/disinfection container, reusable
Penlight by Wenzhou Shengding Industry & Trade Co., Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 697533856penlightQS | Class I | Active |
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Manufacturer
- Manufacturer
- Wenzhou Shengding Industry & Trade Co., Ltd
- EUDAMED SRN
- CN-MF-000009818
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 027107af-df3d-4da1-bf3e-88974875c56e 61 fields · synced Jun 18, 2026