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Lexa MN-111
EUDAMEDFDA 510(k)Class IIb (EU MDR)
Ref 19943110Model 38671Ref 19943111Ref 19943131Ref 19943101Ref 19943100Ref 19943400Ref 19943431
Identity
- Trade Name
- Lexa MN-111 EUDAMED
- Model / Reference
- 38671 EUDAMED19943110 EUDAMED19943111 EUDAMED19943131 EUDAMED19943101 EUDAMED19943100 EUDAMED19943400 EUDAMED19943431 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +E3081994311008 EUDAMED+E3081994311109 EUDAMED+E308199431310B EUDAMED+E3081994310108 EUDAMED+E3081994310007 EUDAMED+E308199434000A EUDAMED+E308199434310E EUDAMED
- Basic UDI-DI
- ++E30838671HP EUDAMED
- EMDN Code
- Z12011305 SMALL LOAD AUTOCLAVES WITH A CHAMBER SMALLER THAN 1 STANDARD STERILISATION UNIT EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Ireland 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
Lexa MN-111 by W&H Sterilization Srl — Class IIb — 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 | K172825 | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | ++E30838671HP | Class IIb | Active |
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Manufacturer
- Manufacturer
- W&H Sterilization Srl
- EUDAMED SRN
- IT-MF-000008237
Sources (8)
- EUDAMED c55d32e4-39e1-4f5e-a21b-6fc56f3f5f37 61 fields · synced Aug 3, 2026
- EUDAMED 843204ce-18da-44b4-b9d0-98d05d7a27c0 61 fields · synced May 17, 2026
- EUDAMED fb762e3c-2df8-4aaa-9af6-774e2bafe555 61 fields · synced May 18, 2026
- EUDAMED 693c1974-7da8-4565-ac05-41d0aeeedee9 61 fields · synced May 18, 2026
- EUDAMED b89fb9e3-2d91-473f-aac9-402653af3d50 61 fields · synced May 18, 2026
- EUDAMED e7598ebd-a4a3-4b08-984a-7919af3b3f9a 61 fields · synced May 18, 2026
- EUDAMED dbc1c19b-6e22-498a-9a57-37fcb75c60b2 61 fields · synced May 18, 2026
- FDA 510(k) K172825 1 fields · synced May 18, 2026