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OBT-65-90 Barraquer 65-90mm Hg Tonometer
EUDAMEDFDA UDIClass I (EU MDR)
Ref 6143
Identity
- Trade Name
- OBT-65-90 Barraquer 65-90mm Hg Tonometer EUDAMEDBarraquer 65-90mm Hg Tonometer FDA UDI
- Generic Name
- Ophthalmic tonometer, manual FDA UDI
- Device Name
- Tonometer EUDAMED
- Model / Reference
- 6143 EUDAMEDOBT-65-90 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00630238061438 EUDAMEDFDA UDI
- Basic UDI-DI
- 0630238126283B EUDAMED
- Direct Marketing DI
- 00630238061193 EUDAMED
- FDA Product Code
- HKY FDA UDI
- EMDN Code
- Q0299 OPHTHALMIC DEVICES - OTHER EUDAMED
- GMDN Term
- Ophthalmic tonometer, manual FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 886.1930 FDA UDI
- Market of Registration
- Austria 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
No
FDA UDI
High-level Disinfectant FDA UDI
OBT-65-90 Barraquer 65-90mm Hg Tonometer by Ocular Instruments, 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 | 0630238126283B | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Ocular Instruments Inc.
- EUDAMED SRN
- US-MF-000007216
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 97512504-f69d-4dfd-95b3-e96240e329b8 61 fields · synced Aug 3, 2026
- FDA UDI af65957b-236e-4472-ae91-acb9ad34a117 32 fields · synced May 30, 2026