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Multi-unit titanium sleeve
EUDAMEDFDA UDIClass I (EU MDR)
Ref MUTSModel Accessories
Identity
- Trade Name
- Multi-unit titanium sleeve EUDAMEDMulti unit titanium sleeve FDA UDI
- Generic Name
- Dental implant system FDA UDI
- Model / Reference
- Accessories EUDAMEDMUTS EUDAMEDAlef FDA UDI
Identifiers
- Catalog Number
- MUTS FDA UDI
- Primary DI / UDI-DI
- 07290018435434 EUDAMEDFDA UDI
- Basic UDI-DI
- 7290018434ACC4S EUDAMED
- 510(k) Number
- K191443 FDA UDI
- FDA Product Code
- NHA FDA UDI
- EMDN Code
- P01020180 DENTAL IMPLANTS - ACCESSORIES EUDAMED
- GMDN Term
- Dental implant system FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3630 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Multi-unit titanium sleeve by MSDI Medical Systems and Devices International Ltd. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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 | 7290018434ACC4S | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- MSDI Medical Systems and Devices International Ltd.
- EUDAMED SRN
- IL-MF-000033949
- Authorised Representative
- MedNet EC-REP IIb GmbH DE-AR-000011192
Sources (2)
- EUDAMED ed8568c9-49c6-4f81-8632-18490b5a9e9d 61 fields · synced Oct 6, 2026
- FDA UDI a2418a5f-ed5e-4a61-b684-53bf6cfaa2f3 34 fields · synced May 30, 2026