Identity
- Trade Name
- M/L-10 Sterilization Tray EUDAMEDM/L-10 FDA UDI
- Generic Name
- Instrument tray, reusable FDA UDI
- Device Name
- Sterilization Trays EUDAMEDM/L-10 Clip Applier Sterilization Tray FDA UDI
- Model / Reference
- 3706 EUDAMEDFDA UDI
- Description
- M/L-10 Clip Applier Sterilization Tray FDA UDI
Identifiers
- Catalog Number
- 3706 FDA UDI
- Primary DI / UDI-DI
- 00811099010852 EUDAMEDFDA UDI
- Basic UDI-DI
- 081109901DOC012SA EUDAMED
- Direct Marketing DI
- 00811099010852 EUDAMED
- FDA Product Code
- KCT FDA UDI
- EMDN Code
- S9080 DEVICES FOR STERILISATION (EXCLUDING CAT. D - Z) - ACCESSORIES EUDAMED
- GMDN Term
- Instrument tray, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 880.6850 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
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
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
M/L-10 Sterilization Tray by Microline Surgical, Inc. — 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 | 081109901DOC012SA | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Microline Surgical, Inc.
- EUDAMED SRN
- US-MF-000009811
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED 7635dfa9-8e6d-4290-8c78-52c39d91e524 61 fields · synced Aug 1, 2026
- FDA UDI 99d4495d-30d5-4891-9ec4-122ce1a985af 34 fields · synced May 30, 2026