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CERALOG® Torque wrench
EUDAMEDFDA UDIClass I (EU MDR)
Ref H5320.1030
by ALTATEC GmbH
Identity
- Trade Name
- CERALOG® Torque wrench EUDAMEDFDA UDI
- Generic Name
- Dental torque wrench FDA UDI
- Device Name
- CERALOG® Torque wrench EUDAMEDCERALOG® Torque wrench, length 83 mm, 15-35 Ncm FDA UDI
- Model / Reference
- H5320.1030 EUDAMEDFDA UDI
- Description
- CERALOG® Torque wrench, length 83 mm, 15-35 Ncm FDA UDI
Identifiers
- Catalog Number
- H5320.1030 FDA UDI
- Primary DI / UDI-DI
- 04099797010718 EUDAMEDE219H532010301 FDA UDI
- Basic UDI-DI
- 40997970008017000000000PK EUDAMED
- Secondary DI
- E219H532010301 EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- P01020180 DENTAL IMPLANTS - ACCESSORIES EUDAMED
- GMDN Term
- Dental torque wrench FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.3980 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
CERALOG® Torque wrench by ALTATEC 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
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 40997970008017000000000PK | Class I | Active |
| EUDAMED | European Union | CE/MDR | 40997970008017000000000PK | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- ALTATEC GmbH
- EUDAMED SRN
- DE-MF-000006230
Sources (2)
- EUDAMED f61cce36-8046-4be9-bbc6-b41c0dda9ecd 61 fields · synced May 31, 2026
- FDA UDI 9ba577b3-be02-4208-8aac-d12f84b30415 35 fields · synced May 29, 2026