HEPRO.US Welcome Pack - Case

FDA UDI

Class II (US FDA UDI)

by Hepro.us Inc.

Identity

Trade Name: HEPRO.US Welcome Pack - Case FDA UDI
Generic Name: Surgical/examination garment kit FDA UDI
Device Name: 1pc Patient Gown, 1pc Round Cup, 1pc, Slipper, 1Pillow Cover 50x 70cm, 1pc Bed Sheet with Elastic 160x 240cm - 30 Non-Sterile Pouch Copy FDA UDI
Model / Reference: CT - Welcome Pack FDA UDI
Description: 1pc Patient Gown, 1pc Round Cup, 1pc, Slipper, 1Pillow Cover 50x 70cm, 1pc Bed Sheet with Elastic 160x 240cm - 30 Non-Sterile Pouch Copy FDA UDI

Identifiers

Primary DI / UDI-DI: 00854427007988 FDA UDI
FDA Product Code: ERY FDA UDI
GMDN Term: Surgical/examination garment kit FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 878.4370 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Safe FDA UDI

Category: Surgical/examination garment kit

HEPRO.US Welcome Pack - Case by Hepro.us Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: Hepro.us Inc.

Sources (1)

FDA UDI d685dcb4-be88-4f8b-bef2-41622ce06237 33 fields · synced May 30, 2026