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single use hemoclips

EUDAMEDFDA UDI

Class IIb (EU MDR)

Ref MD-G-HR-165-12-090-Y

by Zhejiang Chuangxiang Medical Technology Co., LTD.

Identity

Trade Name
single use hemoclips EUDAMED
Single Use Hemoclip FDA UDI
Generic Name
Gastrointestinal endoscopic clip, short-term FDA UDI
Device Name
Single Use Hemoclips EUDAMED
Model / Reference
MD-G-HR-165-12-090-Y EUDAMEDFDA UDI

Identifiers

Primary DI / UDI-DI
06970401814817 EUDAMEDFDA UDI
Basic UDI-DI
697040181HRRotationAV EUDAMED
510(k) Number
K212669 FDA UDI
FDA Product Code
PKL FDA UDI
EMDN Code
G030202 DIGESTIVE ENDOSCOPY, HAEMOSTASIS CLIPS EUDAMED
GMDN Term
Gastrointestinal endoscopic clip, short-term FDA UDI

Classification

Device Class
Class IIb EUDAMED
Class II FDA UDI
Regulation Number
876.4400 FDA UDI
Market of Registration
Austria EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

Sutures

Yes

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

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
MRI Safety
MR Conditional FDA UDI

single use hemoclips by Zhejiang Chuangxiang Medical Technology Co., Ltd. — Class IIb — MDR, FDA UDI — listed in EUDAMED, FDA GUDID

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Zhejiang Chuangxiang Medical Technology Co., LTD.
EUDAMED SRN
CN-MF-000012417
Authorised Representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Sources (2)

  • EUDAMED a8edba3b-b94a-4056-b8ea-9ff02aebced3 61 fields · synced Jun 19, 2026
  • FDA UDI 5b120aea-f060-4c04-9265-ddfe059f9677 33 fields · synced May 29, 2026