Identity
- Trade Name
- Batrik First Check Scope Bag 24" FDA UDI
- Generic Name
- Instrument hygienic-transportation bag FDA UDI
- Device Name
- Your First Transport Bags EUDAMEDTransport Bags fo Endoscope & Medical Instruments (Soiled Instruments Bags), 24"x 22" FDA UDI
- Model / Reference
- 17-SAD24 EUDAMEDFDA UDI
- Description
- Transport Bags fo Endoscope & Medical Instruments (Soiled Instruments Bags), 24"x 22" FDA UDI
Identifiers
- Catalog Number
- 17-SAD24 FDA UDI
- Primary DI / UDI-DI
- 00690521016101 EUDAMEDFDA UDI
- Basic UDI-DI
- 6905210BAGHPYSAD1000LV EUDAMED
- FDA Product Code
- FSM FDA UDI
- EMDN Code
- W05020105 SAMPLES TRANSPORT, BAGS EUDAMED
- GMDN Term
- Instrument hygienic-transportation bag FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Market of Registration
- Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
No
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Your First Transport Bags by Batrik Medical Manufacturing Inc. — Class I — 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 | 6905210BAGHPYSAD1000LV | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Batrik Medical Manufacturing Inc.
- EUDAMED SRN
- CA-MF-000007738
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (2)
- EUDAMED 04435295-4e69-49ea-b165-27febdccb260 61 fields · synced Jul 19, 2026
- FDA UDI 537196d2-dea4-498d-bdcb-3a91b5478003 36 fields · synced May 30, 2026