← Back to catalogue

Sterilized Eol Auto Lancet

FDA UDI

Class II (US FDA UDI)

by Hlb Co., Ltd

Identity

Trade Name
Sterilized Eol Auto Lancet FDA UDI
Generic Name
Fully-implantable middle ear implant system vibrator assembly FDA UDI
Model / Reference
LBAL 28G FDA UDI

Identifiers

Primary DI / UDI-DI
08809262393422 FDA UDI
510(k) Number
K243533 FDA UDI
FDA Product Code
FMK FDA UDI
QRK FDA UDI
GMDN Term
Fully-implantable middle ear implant system vibrator assembly FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4850 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

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

No

FDA UDI

Category: Fully-implantable middle ear implant system vibrator assembly

Sterilized Eol Auto Lancet by Hlb Co., Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K243533 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Hlb Co., Ltd

Sources (1)

  • FDA UDI b74a99cd-2893-4700-8c88-1cf0ec1e5764 34 fields · synced Jun 1, 2026