← Back to catalogue
N61e01-Gh034
EUDAMEDFDA UDIClass I (EU MDR)
Ref N61E01-GH034Model Scrub Shirt, Scrub Shirt Lite, Warm Up Jacket, Scrub Suit, Scrub Suit Lite, Warm Up Jacket Suit, N61E02，N61D04 and other customized specifications
Identity
- Trade Name
- LEBOO FDA UDI
- Generic Name
- Surgical/medical face mask, non-antimicrobial, single-use FDA UDI
- Model / Reference
- Scrub Shirt, Scrub Shirt Lite, Warm Up Jacket, Scrub Suit, Scrub Suit Lite, Warm Up Jacket Suit, N61E02，N61D04 and other customized specifications EUDAMEDN61E01-GH034 EUDAMEDN77A02 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06974424843502 EUDAMEDFDA UDI
- Basic UDI-DI
- 697442484L20QB EUDAMED
- FDA Product Code
- QKR FDA UDI
- EMDN Code
- T0299 PROTECTION DRAPES AND GARMENTS - OTHER EUDAMED
- GMDN Term
- Surgical/medical face mask, non-antimicrobial, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDN FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
N61e01-Gh034 by Leboo Healthcare Products Limited — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697442484L20QB | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Leboo Healthcare Products Limited
- EUDAMED SRN
- CN-MF-000008521
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (2)
- EUDAMED a739267e-9291-4944-a1a7-18b259f9a39d 61 fields · synced Oct 8, 2026
- FDA UDI a6a52cf6-b81b-4c75-98be-6956c202f539 32 fields · synced May 30, 2026