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Dbp-250ht
EUDAMEDFDA UDIClass I (EU MDR)
Ref DBP-250HTModel DBP-250
by GBUK Group
Identity
- Trade Name
- Enteral FDA UDI
- Generic Name
- Gastric drainage/decompression bag FDA UDI
- Device Name
- Enteral ISOSAF Single Use Drainage Bag 250ml FDA UDI
- Model / Reference
- DBP-250 EUDAMEDDBP-250HT EUDAMEDFDA UDI
- Description
- Enteral ISOSAF Single Use Drainage Bag 250ml FDA UDI
Identifiers
- Catalog Number
- DBP-250HT FDA UDI
- Primary DI / UDI-DI
- 05060590889374 EUDAMEDFDA UDI
- Basic UDI-DI
- 506059088EntDrainBagNS9M EUDAMED
- FDA Product Code
- FFD FDA UDI
- EMDN Code
- A060301 COLLECTION BAGS AND OTHER CONTAINERS FOR DRAINAGES AND FISTULAS, SINGLE USE EUDAMED
- GMDN Term
- Gastric drainage/decompression bag FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 876.4370 FDA UDI
- Market of Registration
- Spain 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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Dbp-250ht by GBUK Group — 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 | 506059088EntDrainBagNS9M | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- GBUK Group
- EUDAMED SRN
- GB-MF-000002238
- Authorised Representative
- Qualrep Services B.V. NL-AR-000000537
Sources (2)
- EUDAMED 7e253617-c669-4cd9-889a-a4c3da44bb0f 61 fields · synced Jun 18, 2026
- FDA UDI 962fa9cf-7cb8-41fe-8421-af381f47a986 34 fields · synced May 30, 2026