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Lsan-N61r01-Gh001
EUDAMEDClass I (EU MDR)
Ref LSAN-N61R01-GH001Model Ultrasonic Bonding SMS Isolation Gown、Sterile Isolation Gown、SMS Isolation Gown、N61P01
Identity
- Model / Reference
- Ultrasonic Bonding SMS Isolation Gown、Sterile Isolation Gown、SMS Isolation Gown、N61P01 EUDAMEDLSAN-N61R01-GH001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974424848248 EUDAMED
- Basic UDI-DI
- 697442484L76R6 EUDAMED
- EMDN Code
- T020499 SURGICAL GOWNS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
Yes
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
Lsan-N61r01-Gh001 by Leboo Healthcare Products Limited — 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 | 697442484L76R6 | Class I | Active |
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Manufacturer
- Manufacturer
- Leboo Healthcare Products Limited
- EUDAMED SRN
- CN-MF-000008521
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED c97835eb-5897-434c-b95d-9343b76be704 61 fields · synced Oct 8, 2026