Identity
- Trade Name
- CAPTIVATOR™ EUDAMEDCaptivator EMR FDA UDI
- Generic Name
- Endoscopic electrosurgical mucosal biopsy/resection set FDA UDI
- Device Name
- CaptivatorTM EMR Endoscopic Mucosal Resection Device EUDAMEDEndoscopic Mucosal Resection Device FDA UDI
- Model / Reference
- M00561610 EUDAMEDFDA UDI
- Description
- Endoscopic Mucosal Resection Device FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08714729842699 EUDAMEDFDA UDI
- Basic UDI-DI
- 01915060000000000000041ME EUDAMED
- FDA Product Code
- FDI FDA UDI
- EMDN Code
- G03020399,G03030102 EUDAMED
- GMDN Term
- Endoscopic electrosurgical mucosal biopsy/resection set FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 876.4300 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
Yes
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
Yes
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Endoscopic electrosurgical mucosal biopsy/resection set
Captivator EMR by Boston Scientific — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Endoscopic electrosurgical mucosal biopsy/resection set.
- SmartBand EMR Pack — Intelligent Endoscopy · Class II
- SmartBand EMR Kit — Intelligent Endoscopy · Class II
- ConMed — Provision · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Boston Scientific
Sources (2)
- FDA UDI 37331b57-d4c7-44bc-a3c4-81d4d1c85c11 33 fields · synced Jun 18, 2026
- EUDAMED 38e480ac-e7cf-40fb-b9a7-44962668b1f0 61 fields · synced Jun 4, 2026