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Embrella(TM) Endoscopic Distal Attachment

FDA UDI

Class II (US FDA UDI)

by Micro-Tech (Nanjing) Co., Ltd.

Identity

Trade Name
Embrella(TM) Endoscopic Distal Attachment FDA UDI
Generic Name
Colonoscope distal anchoring cuff FDA UDI
Device Name
The endoscope with a diameter of 12.8-14.5mm is available. The product is standard type of Embrella™ Endoscopic Distal Attachment . FDA UDI
Model / Reference
EM-S-01 FDA UDI
Description
The endoscope with a diameter of 12.8-14.5mm is available. The product is standard type of Embrella™ Endoscopic Distal Attachment . FDA UDI

Identifiers

Primary DI / UDI-DI
06932503560825 FDA UDI
510(k) Number
K190030 FDA UDI
FDA Product Code
FED FDA UDI
GMDN Term
Colonoscope distal anchoring cuff FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.1500 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

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

No

FDA UDI

Category: Colonoscope distal anchoring cuff

Embrella(TM) Endoscopic Distal Attachment by Micro-Tech (Nanjing) Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Colonoscope distal anchoring cuff.

Cleared under the same submission

K190030 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Micro-Tech (Nanjing) Co., Ltd.

Sources (1)

  • FDA UDI 03740cd0-c436-46c0-8d0c-98b41ee4a42d 35 fields · synced May 30, 2026