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Tete Cbm / Altk 200
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 19170/200
by Moria S.A.
Identity
- Trade Name
- TETE CBM / ALTK 200 EUDAMEDMORIA FDA UDI
- Generic Name
- Microkeratome FDA UDI
- Device Name
- TETE CBM / ALTK 200 EUDAMED
- Model / Reference
- 19170/200 EUDAMEDCBM / ALTK HEAD 200 FDA UDI
Identifiers
- Catalog Number
- 19170/200 FDA UDI
- Primary DI / UDI-DI
- 03700483608195 EUDAMEDFDA UDI
- Basic UDI-DI
- B-03700483608195 EUDAMED
- FDA Product Code
- HMY FDA UDI
- EMDN Code
- Z1212020599 MICROKERATOMY INSTRUMENTS - OTHER EUDAMED
- GMDN Term
- Microkeratome FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 886.4370 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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
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
Tete Cbm / Altk 200 by Moria S.A. — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-03700483608195 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Moria S.A.
- EUDAMED SRN
- FR-MF-000000336
Sources (2)
- EUDAMED 9f73f03d-ade9-4545-a1da-8873c9662be5 61 fields · synced Jul 30, 2026
- FDA UDI 5a6a16ff-563d-445a-a183-353b7982a5a7 33 fields · synced May 30, 2026