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single use hemoclips
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref MD-E-HR-230-17-090-YRef MD-E-HR-270-17-135-YRef MD-E-HR-195-17-135-YRef MD-E-HR-270-17-135-NRef MD-E-HR-270-17-090-YRef MD-E-HR-165-17-135-YRef MD-S-HR-230-9-135-YRef MD-G-HR-195-12-090-N-4Ref MD-B-HR-230-20-090-Y-11
Identity
- Trade Name
- single use hemoclips EUDAMEDSingle Use Hemoclip FDA UDI
- Generic Name
- Gastrointestinal endoscopic clip, short-term FDA UDI
- Device Name
- Single Use Hemoclips EUDAMED
- Model / Reference
- MD-E-HR-230-17-090-Y EUDAMEDMD-E-HR-270-17-135-Y EUDAMEDMD-E-HR-195-17-135-Y EUDAMEDMD-E-HR-270-17-135-N EUDAMEDMD-E-HR-270-17-090-Y EUDAMEDMD-E-HR-165-17-135-Y EUDAMEDMD-S-HR-230-9-135-Y EUDAMEDFDA UDIMD-G-HR-195-12-090-N-4 EUDAMEDMD-B-HR-230-20-090-Y-11 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06936534368283 EUDAMED06936534368191 EUDAMED06936534368221 EUDAMED06936534368207 EUDAMED06936534368269 EUDAMED06936534368245 EUDAMED06970401814831 EUDAMEDFDA UDI06942804717460 EUDAMED06942804729975 EUDAMED
- Basic UDI-DI
- 697040181HRRotationAV EUDAMED697040181HRnonRotationUP EUDAMED697040181HRDoubleNRo73 EUDAMED697040181HRSinglewnpRo8W 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 EUDAMEDClass 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
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
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697040181HRRotationAV | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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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 (10)
- EUDAMED c130e614-50d3-4f1c-9ef4-bdcfcce69e5b 61 fields · synced Sep 30, 2026
- EUDAMED ee590e83-d7b5-48e3-b655-c5c7b1a30909 61 fields · synced May 17, 2026
- EUDAMED d7905928-5a2a-4537-a9de-f4bdb24be9a8 61 fields · synced May 17, 2026
- EUDAMED bd44f6c2-38c4-4599-a988-42e7b28c56e5 61 fields · synced May 18, 2026
- EUDAMED 115a6794-4002-48f1-bc1d-fc649eae0ef5 61 fields · synced May 18, 2026
- EUDAMED 925565f0-abea-47f2-b778-203eb01e3d72 61 fields · synced May 18, 2026
- EUDAMED 0e0b4e5f-07dd-494f-ae88-00d0bdeca3b5 61 fields · synced May 18, 2026
- FDA UDI 939b0986-9783-49f2-ba5b-384928f7f7b2 33 fields · synced May 30, 2026
- EUDAMED d2df2c62-84c4-44c9-8a2b-286aecf0545f 61 fields · synced Sep 17, 2026
- EUDAMED 10b0c0e4-cfaf-4bff-ab16-ca4f483bbbbb 61 fields · synced Sep 30, 2026