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Bioteque America, Inc.

FDA UDI

Class II (US FDA UDI)

by Bioteque America, Inc.

Identity

Trade Name
Bioteque America, Inc. FDA UDI
Generic Name
Pelvic-organ-supporting pessary FDA UDI
Device Name
RING PESSARY (w/o) ,R2.25 #2 FDA UDI
Model / Reference
R2 FDA UDI
Description
RING PESSARY (w/o) ,R2.25 #2 FDA UDI

Identifiers

Primary DI / UDI-DI
00810142350020 FDA UDI
FDA Product Code
HHW FDA UDI
GMDN Term
Pelvic-organ-supporting pessary FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
884.3575 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Pelvic-organ-supporting pessary

Bioteque America, Inc. by Bioteque America, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Pelvic-organ-supporting pessary.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Bioteque America, Inc.

Sources (1)

  • FDA UDI 00bbf347-fee9-4d6a-b6ba-c6b639485ca0 33 fields · synced May 30, 2026