Identity
- Trade Name
- Hello, Eyes EUDAMEDFDA UDI
- Generic Name
- Lacrimal punctum plug FDA UDI
- Device Name
- Sterile Polydioxanone Lacrimal Punctum Plug EUDAMEDOur BIO Plug is a medical device designed for the treatment of dry eye syndrome. It is inserted into the lacrimal punctum gland to minimize the drainage of tears through the tear duct, thereby alleviating symptoms of dry eye. FDA UDI
- Model / Reference
- Bio Plug 0.5 EUDAMEDFDA UDI
- Description
- Our BIO Plug is a medical device designed for the treatment of dry eye syndrome. It is inserted into the lacrimal punctum gland to minimize the drainage of tears through the tear duct, thereby alleviating symptoms of dry eye. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800024300016 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08800024300016 EUDAMED
- 510(k) Number
- K241229 FDA UDI
- FDA Product Code
- LZU FDA UDI
- EMDN Code
- Q020703 LACRIMAL DUCT PLUGS EUDAMED
- GMDN Term
- Lacrimal punctum plug FDA UDI
Classification
- Device Class
- Class III EUDAMEDU FDA UDI
- Market of Registration
- Lithuania EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
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
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Lacrimal punctum plug
Hello, Eyes by Bio Optics Co., Ltd — Class III — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Lacrimal punctum plug.
- SuperFlex — Katena Products, Inc. · U
- Diamatrix — Diamatrix · U
- Lacrimal Plug — RIVERPOINT MEDICAL LLC · U
- Comfortear Lacrisolve 180 Absorbable Punctum Plug — RIVERPOINT MEDICAL LLC · U
- Diamatrix — Diamatrix · U
- SOFT PLUG® Silicone Punctum Plug — OASIS Medical, Inc. · U
- Stephens Instruments — KRISHNA IMPORTS INC · U
- Lacrivera — STEPHENS INSTRUMENTS, INC · Class IIb
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-08800024300016 | Class III | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
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Manufacturer
- Manufacturer
- BIO Optics Co., Ltd
- EUDAMED SRN
- KR-MF-000042788
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (2)
- EUDAMED 848722f9-b649-457a-a9a9-8335d6ae2bf0 61 fields · synced Jul 24, 2026
- FDA UDI 840fdf04-6554-4718-a96c-ec4fbdb3d39f 34 fields · synced May 30, 2026