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PENTAX Balloon OE-A51
EUDAMEDFDA UDIClass I (EU MDR)
Ref 6217001Z850SModel OE-A51
Identity
- Trade Name
- PENTAX Balloon OE-A51 EUDAMEDPENTAX FDA UDI
- Generic Name
- Ultrasound endoscope balloon, synthetic polymer FDA UDI
- Device Name
- PENTAX Balloon OE-A51 EUDAMEDBALLOON FDA UDI
- Model / Reference
- OE-A51 EUDAMEDFDA UDI6217001Z850S EUDAMED
- Description
- BALLOON FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04961333123339 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04961333123339 EUDAMED
- 510(k) Number
- K130206 FDA UDI
- FDA Product Code
- ODG FDA UDI
- EMDN Code
- G0380 DIGESTIVE ENDOSCOPY DEVICES - ACCESSORIES EUDAMED
- GMDN Term
- Ultrasound endoscope balloon, synthetic polymer FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
Yes
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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
No
FDA UDI
Category: Gastro-urological guidewire, single-use
PENTAX Balloon OE-A51 by HOYA Corporation — Class I — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Also classified as Gastro-urological guidewire, single-use.
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-04961333123339 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- HOYA Corporation
- EUDAMED SRN
- JP-MF-000005227
- Authorised Representative
- PENTAX Europe GmbH DE-AR-000000006
Sources (2)
- EUDAMED 6c144c31-eea8-4811-9bf9-729d6f253419 61 fields · synced Jul 21, 2026
- FDA UDI 8ca60526-85df-427b-9037-181aad949a13 35 fields · synced May 30, 2026