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Burnshield
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref L550009Ref L550023Ref L881080Ref L900814Ref L900800Ref L550013Ref L900817Ref L901000Ref L900802Ref L903001Ref L901111Ref L900818Ref L550000Ref L550008Ref L900824Ref L550010
Identity
- Trade Name
- Burnshield EUDAMEDFDA UDI
- Generic Name
- Burn gel FDA UDISynthetic polymer burn dressing, gel-coated FDA UDI
- Device Name
- Burnshield Hydrogel Tube 25ml (0.85oz) EUDAMEDBurnshield Cartridges 150g (5.29oz) EUDAMEDBurnshield Burn Vest 6-12 Months EUDAMEDBURNSHIELD HYDROGEL BOTTLE 50ML (1.8OZ) EUDAMEDFDA UDIBURNSHIELD CATER KIT EUDAMEDFDA UDIBURNSHIELD EMERGENCY KIT IN NYLON BAG EUDAMEDFDA UDIBURNSHIELD ESSENTIAL BURN KIT SMALL EUDAMEDFDA UDIBURNSHIELD MINI BURN KIT EUDAMEDFDA UDIBurnshield Responder Kit in Nylon Bag EUDAMEDBurnshield Combi Trauma Burn Kit EUDAMEDBurnshield Face Mask Dressing 200mmx450mm (8"x18") EUDAMEDBurnshield Multi Pack EUDAMEDBurnshield Dressing 100mm x 100mm (4" x4") EUDAMEDBurnshield Home Kit 10B EUDAMEDBurnshield Prestige Kit - Grand (L) EUDAMEDBurnshield Hydrogel Tube 10ml (0.35oz) EUDAMEDBURNSHIELD HYDROGEL TUBE 25ML (0.85 OZ) FDA UDIBURNSHIELD 20X45CM FACEMASK FDA UDIBURNSHIELD HYDROGEL TUBE 10ML (0.35 OZ) FDA UDIBURNSHIELD 10X10CM DRESSINGS IN BULK FDA UDI
- Model / Reference
- L550009 EUDAMEDL550023 EUDAMEDL881080 EUDAMEDL900814 EUDAMEDL900800 EUDAMEDL550013 EUDAMEDL900817 EUDAMEDL901000 EUDAMEDL900802 EUDAMEDL903001 EUDAMEDL901111 EUDAMEDL900818 EUDAMEDL550000 EUDAMEDL550008 EUDAMEDL900824 EUDAMEDL550010 EUDAMED550000 FDA UDI903001 FDA UDI900817 FDA UDI550009 FDA UDI900818 FDA UDI901000 FDA UDI550010 FDA UDI901111 FDA UDI550013 FDA UDI
- Description
- BURNSHIELD HYDROGEL BOTTLE 50ML (1.8OZ) FDA UDIBURNSHIELD CATER KIT FDA UDIBURNSHIELD EMERGENCY KIT IN NYLON BAG FDA UDIBURNSHIELD HYDROGEL TUBE 25ML (0.85 OZ) FDA UDIBURNSHIELD ESSENTIAL BURN KIT SMALL FDA UDIBURNSHIELD 20X45CM FACEMASK FDA UDIBURNSHIELD HYDROGEL TUBE 10ML (0.35 OZ) FDA UDIBURNSHIELD 10X10CM DRESSINGS IN BULK FDA UDIBURNSHIELD MINI BURN KIT FDA UDI
Identifiers
- Catalog Number
- 550000 FDA UDI903001 FDA UDI900817 FDA UDI550009 FDA UDI900818 FDA UDI901000 FDA UDI550010 FDA UDI901111 FDA UDI550013 FDA UDI
- Primary DI / UDI-DI
- 06007645005302 EUDAMEDFDA UDI06007645007153 EUDAMED06007645004329 EUDAMED06007645000123 EUDAMEDFDA UDI06007645002004 EUDAMEDFDA UDI06007645007924 EUDAMEDFDA UDI06007645005784 EUDAMEDFDA UDI06007645001458 EUDAMEDFDA UDI06007645004596 EUDAMEDFDA UDI06007645001380 EUDAMEDFDA UDI06007645001540 EUDAMEDFDA UDI06007645002059 EUDAMED06007645002325 EUDAMED06007645002042 EUDAMED06007645001564 EUDAMED06007645010238 EUDAMED
- Basic UDI-DI
- B-06007645005302 EUDAMEDB-06007645007153 EUDAMEDB-06007645004329 EUDAMEDB-06007645002059 EUDAMEDB-06007645002325 EUDAMEDB-06007645001540 EUDAMEDB-06007645007924 EUDAMEDB-06007645001458 EUDAMEDB-06007645002042 EUDAMEDB-06007645002004 EUDAMEDB-06007645001380 EUDAMEDB-06007645005784 EUDAMEDB-06007645000123 EUDAMEDB-06007645001564 EUDAMEDB-06007645010238 EUDAMEDB-06007645004596 EUDAMED
- 510(k) Number
- K943728 FDA UDI
- FDA Product Code
- MGQ FDA UDI
- EMDN Code
- M0408 DRESSINGS FOR BURNS ONLY EUDAMED
- GMDN Term
- Burn gel FDA UDISynthetic polymer burn dressing, gel-coated FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDU 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 UDIEUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDIFDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Total Volume — 50 Milliliter FDA UDITotal Volume — 25 Milliliter FDA UDIWeight — 270 Gram FDA UDIWidth — 450 Millimeter FDA UDILength — 200 Millimeter FDA UDITotal Volume — 10 Milliliter FDA UDIWeight — 40 Gram FDA UDIWidth — 100 Millimeter FDA UDILength — 100 Millimeter FDA UDI
Burnshield by Burnshield (pty) Ltd — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06007645005302 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Burnshield (Pty) Ltd
- EUDAMED SRN
- ZA-MF-000018376
- Authorised Representative
- Burnshield Europe B.V. NL-AR-000014621
Sources (25)
- EUDAMED b50511f4-8b70-466b-a1e7-9850817dd33d 61 fields · synced Jul 30, 2026
- EUDAMED f7b568ea-d094-4318-8336-dbda1fd8c56b 61 fields · synced May 17, 2026
- EUDAMED b0dae4a5-712b-40fa-9a82-30ed72a1906f 61 fields · synced May 18, 2026
- FDA UDI 7ba7e284-c846-4658-b727-03d0ba125228 38 fields · synced May 29, 2026
- FDA UDI 3b591bf5-6106-4dd6-9351-17db4a4e9c9a 37 fields · synced May 30, 2026
- FDA UDI 123354ce-ccc6-4bc4-8e87-f4757a969146 37 fields · synced May 30, 2026
- FDA UDI 741c8445-5d3e-4a7c-9492-95bc784d4353 38 fields · synced May 30, 2026
- FDA UDI e68e9df2-c167-4126-9f6a-f5b7369fcab5 37 fields · synced May 30, 2026
- FDA UDI 7da89f4b-b1eb-4169-bc6e-f59286a9b5e1 38 fields · synced May 30, 2026
- FDA UDI beb8dfea-8e04-4c62-9b18-e1fb5bb79fc2 38 fields · synced May 30, 2026
- FDA UDI 9bfcae76-17e4-4fd8-b566-3fdaa14385f4 38 fields · synced May 30, 2026
- FDA UDI 3fc6b08d-eec6-4fd1-8558-db64e516f741 37 fields · synced May 30, 2026
- EUDAMED fbcf9ec3-4cf2-4522-9234-352af8dbd6f1 61 fields · synced Jul 9, 2026
- EUDAMED 492a7e84-5ce6-4a59-8f2e-c458ecdbd25f 61 fields · synced Jul 9, 2026
- EUDAMED 36c771cd-57cb-4fc8-a3d5-e1c24b579a22 61 fields · synced Jul 9, 2026
- EUDAMED c9f65387-ba33-4a60-98d9-e8d97858d715 61 fields · synced Jul 11, 2026
- EUDAMED 6184a77a-1170-4001-81ad-4f037be7b054 61 fields · synced Jul 11, 2026
- EUDAMED cac6e864-00cc-43d4-a092-73751c2c7331 61 fields · synced Jul 13, 2026
- EUDAMED 76d8c4bd-9dda-4578-b95f-f0b89509643a 61 fields · synced Jul 14, 2026
- EUDAMED 18aff263-a065-4bab-8fb9-05d573f9df29 61 fields · synced Jul 17, 2026
- EUDAMED b139c698-df9e-4b36-b37f-afdf100c868d 61 fields · synced Jul 18, 2026
- EUDAMED e957c197-28d1-4227-aa83-0491a9b57f86 61 fields · synced Jul 25, 2026
- EUDAMED a6ab588e-fb97-40e0-8286-e0d447e36d47 61 fields · synced Jul 25, 2026
- EUDAMED f4cd2bc4-b69d-4e45-ab77-47d948de99d6 61 fields · synced Jul 29, 2026
- EUDAMED e3b72cfb-de9e-4c46-b923-7eb1b518e0e9 61 fields · synced Jul 30, 2026