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ioConnect Screw
EUDAMEDClass I (EU MDR)
Ref IOW14H12(10) Ref IOW18H12(10) Ref IOW14H12L(10) Ref IOW14H12S(10)
Identity
- Trade Name
- ioConnect Screw EUDAMED
- Device Name
- Dental Scan Body Components (Individual) EUDAMED
- Model / Reference
- IOW14H12(10) EUDAMEDIOW18H12(10) EUDAMEDIOW14H12L(10) EUDAMEDIOW14H12S(10) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800076475311 EUDAMED08800076475328 EUDAMED08800076475304 EUDAMED08800076475335 EUDAMED
- Basic UDI-DI
- 88000764SBRYY EUDAMED
- EMDN Code
- P01020180 DENTAL IMPLANTS - ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMED
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
ioConnect Screw by TruAbutment Inc. — Class I — 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 | 88000764SBRYY | Class I | Active |
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Manufacturer
- Manufacturer
- TruAbutment Inc.
- EUDAMED SRN
- US-MF-000043448
- Authorised Representative
- AeMi World e.K DE-AR-000007704
Sources (4)
- EUDAMED b9a42f4f-0713-446f-bec0-1151a3826e55 61 fields · synced Aug 3, 2026
- EUDAMED e2294afc-6132-4f6f-808a-c3e462089b7f 61 fields · synced May 16, 2026
- EUDAMED 677d71bf-1287-4036-8448-200c1ac006b4 61 fields · synced May 17, 2026
- EUDAMED f5f3cbca-0bad-4059-824b-56204d23e4d4 61 fields · synced May 18, 2026