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N61b01
EUDAMEDClass I (EU MDR)
Ref N61B01Model PP Isolation Gown, PE Coated Isolation Gown, Half PE Coated Isolation Gown, SMS Isolation Gown, Surgical Isolation Gown, Patient Gown With Short Sleeve, Patient Gown Without Sleeve, Lab Coat With Velcro, Lab Coat With Press Button,etc
Identity
- Model / Reference
- PP Isolation Gown, PE Coated Isolation Gown, Half PE Coated Isolation Gown, SMS Isolation Gown, Surgical Isolation Gown, Patient Gown With Short Sleeve, Patient Gown Without Sleeve, Lab Coat With Velcro, Lab Coat With Press Button,etc EUDAMEDN61B01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974424849450 EUDAMED
- Basic UDI-DI
- 697442484L03QB EUDAMED
- EMDN Code
- T0299 PROTECTION DRAPES AND GARMENTS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands 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
N61b01 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 | 697442484L03QB | 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 813631f7-8e90-4844-9e12-d1fa471c3195 61 fields · synced Oct 7, 2026