← Back to catalogue
disposable endoscopic biopsy needle
EUDAMEDClass IIa (EU MDR)
Ref AEB/S221814WModel /
Identity
- Device Name
- disposable endoscopic biopsy needle EUDAMED
- Model / Reference
- / EUDAMEDAEB/S221814W EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16974837940505 EUDAMED
- Basic UDI-DI
- 69748379401A00158 EUDAMED
- Direct Marketing DI
- 16974837940505 EUDAMED
- EMDN Code
- A01020199 NEEDLES AND KITS FOR HISTOLOGICAL AND CYTOLOGICAL BIOPSY OF SOFT TISSUES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Türkiye 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
disposable endoscopic biopsy needle by PureMED Product (Yangzhou) 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 | 69748379401A00158 | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- PureMED Product (Yangzhou) Co., Ltd.
- EUDAMED SRN
- CN-MF-000013490
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED f5c59ac6-44ea-4c72-a9d2-8225bb601503 61 fields · synced Jul 17, 2026