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Biopsy Needle
EUDAMEDClass IIa (EU MDR)
Ref AF-D1908XAPModel Biopsy NeedleRef AF-D2208XASRef AF-D2208XAPRef AF-D2508XBSRef AF-D2213XBSRef AF-D1908XBSRef AF-D1913XBPRef AF-D2208XBSRef AF-D1908XBP
Identity
- Trade Name
- Biopsy Needle EUDAMED
- Device Name
- Biopsy Needle EUDAMED
- Model / Reference
- Biopsy Needle EUDAMEDAF-D1908XAP EUDAMEDAF-D2208XAS EUDAMEDAF-D2208XAP EUDAMEDAF-D2508XBS EUDAMEDAF-D2213XBS EUDAMEDAF-D1908XBS EUDAMEDAF-D1913XBP EUDAMEDAF-D2208XBS EUDAMEDAF-D1908XBP EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942127816291 EUDAMED06942127816321 EUDAMED06942127816314 EUDAMED06942127859755 EUDAMED06942127859793 EUDAMED06942127859717 EUDAMED06942127859762 EUDAMED06942127859731 EUDAMED06942127859700 EUDAMED
- Basic UDI-DI
- 697067138AN035CP EUDAMED
- EMDN Code
- A0102010101 SHEARING BIOPSY NEEDLES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
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
Biopsy Needle by Alton (Shanghai) Medical Instruments Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697067138AN035CP | Class IIa | Active |
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Manufacturer
- Manufacturer
- Alton (Shanghai) Medical Instruments Co., Ltd.
- EUDAMED SRN
- CN-MF-000012832
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (9)
- EUDAMED 979c47f3-509a-4c2d-a824-311a504e5c5d 61 fields · synced Oct 6, 2026
- EUDAMED 2221c8c9-e556-46e0-aa02-160517d28292 61 fields · synced Jun 14, 2026
- EUDAMED 51833912-edf8-4b3c-a6cc-7cb1aa8ed8c6 61 fields · synced Jul 9, 2026
- EUDAMED 12c1cb17-4189-4625-a583-8ac67dc484af 61 fields · synced Jul 11, 2026
- EUDAMED 2d74f6fe-c8d2-4b3e-89f4-7cd4537c84eb 61 fields · synced Jul 12, 2026
- EUDAMED f869e56d-bdfa-481b-8fd6-f5bcbcdc8a5f 61 fields · synced Jul 14, 2026
- EUDAMED f5894c2e-9ce8-4991-b542-34c39265ecf4 61 fields · synced Jul 20, 2026
- EUDAMED a3f93873-ab9f-43d1-b221-a66b35650a6a 61 fields · synced Jul 21, 2026
- EUDAMED 65a5b7c9-94de-48a4-8eb7-83c32b1413d3 61 fields · synced Jul 28, 2026