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Cervical Biopsy Punch
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref CBT1001BModel Cervical Biopsy Punch Ref CBR1041
Identity
- Trade Name
- Cervical Biopsy Punch EUDAMEDFDA UDI
- Generic Name
- Open-surgery biopsy forceps, single-use FDA UDI
- Device Name
- Cervical biopsy punch with rotation FDA UDI
- Model / Reference
- Cervical Biopsy Punch EUDAMEDCBT1001B EUDAMEDCBR1041 EUDAMED1 FDA UDI
- Description
- Cervical biopsy punch with rotation FDA UDI
Identifiers
- Catalog Number
- CBR1041 FDA UDI
- Primary DI / UDI-DI
- 05060212052100 EUDAMED05060411985339 EUDAMEDFDA UDI
- Basic UDI-DI
- 506021205TF28XN EUDAMED
- FDA Product Code
- HFB FDA UDI
- EMDN Code
- U09030199 FORCEPS FOR UROGENITAL ENDOSCOPY, SINGLE-USE - OTHER EUDAMED
- GMDN Term
- Open-surgery biopsy forceps, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 884.4530 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Length — 365 Millimeter FDA UDI
Cervical Biopsy Punch by Dtr Medical Ltd — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 | 506021205TF28XN | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Dtr Medical Ltd
- EUDAMED SRN
- GB-MF-000023112
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (3)
- EUDAMED 2a740404-4ff7-4eab-ab95-3195ff3a942d 61 fields · synced Jul 23, 2026
- EUDAMED 43ed5fd4-bd06-4ec8-a2fc-17f25b236957 61 fields · synced May 18, 2026
- FDA UDI 23adcc2d-e2b6-4c42-ab44-06b7c39580c7 35 fields · synced May 30, 2026