BioPure HX2

FDA UDI

Class II (US FDA UDI)

by Biolab Equipment Ltd

Identity

Trade Name: BioPure HX2 FDA UDI
Generic Name: Reverse-osmosis water purification system FDA UDI
Model / Reference: HX2P-05811XX FDA UDI

Identifiers

Primary DI / UDI-DI: 00817492021839 FDA UDI
510(k) Number: K133149 FDA UDI
FDA Product Code: FIP FDA UDI
GMDN Term: Reverse-osmosis water purification system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 876.5665 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size: Weight — 2504 Pound FDA UDI
Height — 82 Inch FDA UDI
Depth — 37 Inch FDA UDI
Width — 166 Inch FDA UDI

Category: Reverse-osmosis water purification system

BioPure HX2 by Biolab Equipment Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K133149 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Biolab Equipment Ltd

Sources (1)

FDA UDI 84b90b48-8cca-4033-81c5-252a1f0f499b 36 fields · synced May 30, 2026