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Laitest Surgical Face Mask
EUDAMEDFDA 510(k)Class I (EU MDR)
Ref LASG0001Model LASG0001 LAMA0001 LAMA0002
Identity
- Device Name
- LAITEST SURGICAL FACE MASK EUDAMED
- Model / Reference
- LASG0001 LAMA0001 LAMA0002 EUDAMEDLASG0001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04710970381004 EUDAMED
- Basic UDI-DI
- 471097038LSFM01D7 EUDAMED
- EMDN Code
- T020603 MEDICAL USE FACE MASKS, TYPE I (NOT FOR HEALTHCARE PROFESSIONALS) 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
Laitest Surgical Face Mask by R&R Medical Corporation Ltd. — Class I — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K214035 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 471097038LSFM01D7 | Class I | Active |
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Manufacturer
- Manufacturer
- R&R Medical Corporation Ltd.
- EUDAMED SRN
- TW-MF-000029155
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (2)
- EUDAMED 90f28ca6-8054-4907-a216-6e6e8d4e3a6b 61 fields · synced Sep 17, 2026
- FDA 510(k) K214035 1 fields · synced May 18, 2026