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OKBT-20-30 Kasaby Barraquer 20-30mm Hg Tonometer
EUDAMEDFDA UDIClass I (EU MDR)
Ref 9979
Identity
- Trade Name
- OKBT-20-30 Kasaby Barraquer 20-30mm Hg Tonometer EUDAMEDKasaby Barraquer 20-30mm Hg Tonometer FDA UDI
- Generic Name
- Ophthalmic tonometer, manual FDA UDI
- Device Name
- Tonometer EUDAMED
- Model / Reference
- 9979 EUDAMEDOKBT-20-30 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00630238099790 EUDAMEDFDA UDI
- Basic UDI-DI
- 0630238126283B EUDAMED
- Direct Marketing DI
- 00630238099844 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
OKBT-20-30 Kasaby Barraquer 20-30mm Hg Tonometer by Ocular Instruments, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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 30720392-57d9-4d2c-99ed-8c2af1c4e60f 61 fields · synced Jun 18, 2026
- FDA UDI ec18b1b2-1d78-425a-b0aa-d63ef45624c5 32 fields · synced May 26, 2026