Identity
- Trade Name
- m-protect®3 EUDAMEDm-protect3 FDA UDI
- Generic Name
- Endoscopic-access dilator, single-use FDA UDI
- Device Name
- m-protect EUDAMEDm-protect®3 is intended exclusively for use as an insertion guide of circular stapler instruments used for transanal stapled anastomosis. FDA UDI
- Model / Reference
- MP0028/29 EUDAMED28/29 FDA UDI
- Description
- m-protect®3 is intended exclusively for use as an insertion guide of circular stapler instruments used for transanal stapled anastomosis. FDA UDI
Identifiers
- Catalog Number
- MP0028/29 FDA UDI
- Primary DI / UDI-DI
- 04262358420114 EUDAMED04262358420022 FDA UDI
- Basic UDI-DI
- 426235842CE-MED000001KK EUDAMED
- Unit of Use DI
- 04262358420022 EUDAMED
- FDA Product Code
- KOA FDA UDI
- EMDN Code
- H020280 STAPLERS FOR OPEN SURGERY - ACCESSORIES EUDAMED
- GMDN Term
- Endoscopic-access dilator, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 876.4730 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
Yes
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
No
FDA UDI
m-protect®3 by qtec CE-med GmbH — 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 | 426235842CE-MED000001KK | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- qtec CE-Med GmbH
- EUDAMED SRN
- DE-MF-000024308
Sources (2)
- EUDAMED 09b5e432-f9f6-4232-92be-2be741c22a46 61 fields · synced May 31, 2026
- FDA UDI 8ac673cc-4032-401b-ad1b-f9cc198d3783 37 fields · synced May 30, 2026