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Dental Implant, ROOTT R, D 3.5 mm, L 16 mm.
EUDAMEDClass IIb (EU MDR)
Ref R3516Model Dental implant, ROOTT RRef R5516
by Trate Ag
Identity
- Trade Name
- Dental Implant, ROOTT R, D 3.5 mm, L 16 mm. EUDAMEDDental Implant, ROOTT R, D 5.5 mm, L 16 mm. EUDAMED
- Model / Reference
- Dental implant, ROOTT R EUDAMEDR3516 EUDAMEDR5516 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 17630053808164 EUDAMED17630053800106 EUDAMED17630053809567 EUDAMED17630053809765 EUDAMED
- Basic UDI-DI
- 76300538ROOTTRTX EUDAMED
- EMDN Code
- P01020101 DENTAL IMPLANTS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Poland EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Sutures
Yes
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
Dental Implant, ROOTT R, D 3.5 mm, L 16 mm. by Trate Ag — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 76300538ROOTTRTX | Class IIb | Active |
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Manufacturer
Sources (4)
- EUDAMED aeeb0571-f6a0-4e34-b2f2-1ca2ee19a0cc 61 fields · synced Oct 6, 2026
- EUDAMED 8750355c-618a-40c7-97be-ca57f500db80 61 fields · synced May 17, 2026
- EUDAMED a19d8b35-36d5-4c09-8dba-39dd3a62a4b7 61 fields · synced May 18, 2026
- EUDAMED 5b280a7d-3ab9-4865-97de-6b044cff6945 61 fields · synced May 19, 2026