Identity
- Trade Name
- Retrax BK-1 Probe EUDAMEDBK PROBE FDA UDI
- Generic Name
- Dental surgical probe, reusable FDA UDI
- Device Name
- Generic Devices EUDAMEDPERIODONTAL PROBE/EXPLORER FDA UDI
- Model / Reference
- 26230 EUDAMEDFDA UDI
- Description
- PERIODONTAL PROBE/EXPLORER FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00310866002583 EUDAMEDFDA UDI
- Basic UDI-DI
- 03108669002HH EUDAMED
- FDA Product Code
- EKB FDA UDI
- EMDN Code
- Z12119004 EQUIPMENT FOR DIAGNOSIS OF PERIODONTAL DISEASES EUDAMED
- GMDN Term
- Dental surgical probe, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.4565 FDA UDI
- Market of Registration
- Bulgaria 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
No
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
No
FDA UDI
Retrax BK-1 Probe by Pascal Company, Inc. — 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
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 03108669002HH | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Pascal Company Inc.
- EUDAMED SRN
- US-MF-000032036
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED b15e9096-7800-443e-99a4-3c16c65ffce7 61 fields · synced Jun 18, 2026
- FDA UDI fdf6dd4f-ee3a-4388-b5da-dd6e3219df70 34 fields · synced May 26, 2026